MELPHALAN HYDROCHLORIDE kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MELPHALAN HYDROCHLORIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9510P)
Available from:
Fosun Pharma USA Inc
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Melphalan hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent. Patients who have demonstrated hypersensitivity to melphalan should not be given the drug.
Product summary:
Melphalan Hydrochloride for Injection is supplied as follows: NDC Melphalan Hydrochloride for Injection (Kit) Package Factor 72266-128-01 Single-Dose Vial of Melphalan Hydrochloride for Injection and 10 mL Vial of Sterile Diluent 1 vial per carton 1 vial per carton Each carton contains one single-dose clear glass vial of lyophilized melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.
Authorization status:
Abbreviated New Drug Application
Authorization number:
72266-128-01, 72266-144-01, 72266-145-01

MELPHALAN HYDROCHLORIDE- melphalan hydrochloride

Fosun Pharma USA Inc

----------

Melphalan Hydrochloride for Injection

(For Intravenous Infusion)

Rx only

BOXED WARNING

Melphalan should be administered under the supervision of a qualified physician experienced in

the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting

infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral melphalan

have shown more myelosuppression with the IV formulation. Hypersensitivity reactions,

including anaphylaxis, have occurred in approximately 2% of patients who received the IV

formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations

in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.

Melphalan, also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a

phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent that is active

against selected human neoplastic diseases. It is known chemically as 4-[bis(2-chloroethyl)amino]- L-

phenylalanine. The molecular formula is C

and the molecular weight is 305.20. The

structural formula is:

melphalan-structure

Melphalan is the active L-isomer of the compound and was first synthesized in 1953 by Bergel and

Stock; the D-isomer, known as medphalan, is less active against certain animal tumors, and the dose

needed to produce effects on chromosomes is larger than that required with the L-isomer. The racemic

(DL-) form is known as melphalan or sarcolysin.

Melphalan is practically insoluble in water and has a pKa

2.5.

Melphalan hydrochloride for Injection is supplied as a sterile, nonpyrogenic, white to off white

lyophilized cake or powder. Each single-use vial contains melphalan hydrochloride equivalent to 50 mg

melphalan and 20 mg povidone. Melphalan hydrochloride for Injection is reconstituted using the sterile

diluent provided. Each vial of sterile diluent contains sodium citrate 0.2 g, propylene glycol 6 mL,

ethanol (96%) 0.52 mL, and Water for Injection to a total of 10 mL. Melphalan hydrochloride for

Injection is administered intravenously.

CLINICAL PHARMACOLOGY

Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to

be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position

of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing

tumor cells.

Pharmacokinetics: Following injection, drug plasma concentrations declined rapidly in a biexponential

manner with distribution phase and terminal elimination phase half-lives of approximately 10 and 75

minutes, respectively. Estimates of average total body clearance varied among studies, but typical

values of approximately 7 to 9 mL/min/kg (250 to 325 mL/min/m2) were observed. One study has

reported that on repeat dosing of 0.5 mg/kg every 6 weeks, the clearance of melphalan decreased from

8.1 mL/min/kg after the first course, to 5.5 mL/min/kg after the third course, but did not decrease

appreciably after the third course. Mean (±SD) peak melphalan plasma concentrations in myeloma

patients given IV melphalan at doses of 10 or 20 mg/m2 were 1.2 ± 0.4 and 2.8 ± 1.9 mcg/mL,

respectively.

The steady-state volume of distribution of melphalan is 0.5 L/kg. Penetration into cerebrospinal fluid

(CSF) is low. The average melphalan binding to plasma proteins is highly variable (range: 53% to 92%).

Serum albumin is the major binding protein, accounting for approximately 40% to 60% of the plasma

protein binding, while α1-acid glycoprotein accounts for about 20% of the plasma protein binding.

Approximately 30% of melphalan is (covalently) irreversibly bound to plasma proteins. Interactions

with immunoglobulins have been found to be negligible.

Melphalan is eliminated from plasma primarily by chemical hydrolysis to monohydroxymelphalan and

dihydroxymelphalan. Aside from these hydrolysis products, no other melphalan metabolites have been

observed in humans. Although the contribution of renal elimination to melphalan clearance appears to be

low, one study noted an increase in the occurrence of severe leukopenia in patients with elevated BUN

after 10 weeks of therapy.

Clinical Trial: A randomized trial compared prednisone plus IV melphalan to prednisone plus oral

melphalan in the treatment of myeloma. As discussed below, overall response rates at week 22 were

comparable; however, because of changes in trial design, conclusions as to the relative activity of the 2

formulations after week 22 are impossible to make.

Both arms received oral prednisone starting at 0.8 mg/kg/day with doses tapered over 6 weeks.

Melphalan doses in each arm were:

Arm 1: Oral melphalan 0.15 mg/kg/day x 7 followed by 0.05 mg/kg/day when WBC began to rise.

Arm 2: IV melphalan 16 mg/m2 q 2 weeks x 4 (over 6 weeks) followed by the same dose every 4 weeks.

Doses of melphalan were adjusted according to the following criteria:

Table 1. Criteria for Dosage Adjustment in a Randomized Clinical Trial

WBC/mm3

Platelets

Percent of Full Dose

≥4,000

≥100,000

≥3,000

≥75,000

≥2,000

≥50,000

<2,000

<50,000

One hundred seven patients were randomized to the oral melphalan arm and 203 patients to the IV

melphalan arm. More patients had a poor-risk classification (58% versus 44%) and high tumor load

(51% versus 34%) on the oral compared to the IV arm (P<0.04). Response rates at week 22 are shown in

the following table:

Table 2. Response Rates at Week 22

Evaluable

Responders

Initial Arm

Evaluable

Patients

Responders

n (%)

P

Oral melphalan

44 (44%)

P>0.2

IV melphalan

74 (38%)

P>0.2

Because of changes in protocol design after week 22, other efficacy parameters such as response

duration and survival cannot be compared.

Severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) was more common in the IV melphalan

arm (28%) than in the oral melphalan arm (11%).

An association was noted between poor renal function and myelosuppression; consequently, an

amendment to the protocol required a 50% reduction in IV melphalan dose if the BUN was ≥30 mg/dL.

The rate of severe leukopenia in the IV arm in the patients with BUN over 30 mg/dL decreased from

50% (8/16) before protocol amendment to 11% (3/28) (P = 0.01) after the amendment.

Before the dosing amendment, there was a 10% (8/77) incidence of drug-related death in the IV arm.

After the dosing amendment, this incidence was 3% (3/108). This compares to an overall 1% (1/100)

incidence of drug-related death in the oral arm.

INDICATIONS & USAGE

Melphalan hydrochloride for Injection is indicated for the palliative treatment of patients with multiple

myeloma for whom oral therapy is not appropriate.

CONTRAINDICATIONS

Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent.

Patients who have demonstrated hypersensitivity to melphalan should not be given the drug.

WARNINGS

Melphalan hydrochloride for Injection may cause local tissue damage should extravasation occur, and

consequently it should not be administered by direct injection into a peripheral vein. It is recommended

that Melphalan hydrochloride for Injection be administered by injecting slowly into a fast-running IV

infusion via an injection port, or via a central venous line (see DOSAGE AND ADMINISTRATION:

Administration Precautions).

Melphalan should be administered in carefully adjusted dosage by or under the supervision of

experienced physicians who are familiar with the drug's actions and the possible complications of its

use.

As with other nitrogen mustard drugs, excessive dosage will produce marked bone marrow

suppression. Bone marrow suppression is the most significant toxicity associated with Melphalan

hydrochloride for Injection in most patients. Therefore, the following tests should be performed at the

start of therapy and prior to each subsequent dose of Melphalan hydrochloride: platelet count,

hemoglobin, white blood cell count, and differential. Thrombocytopenia and/or leukopenia are

indications to withhold further therapy until the blood counts have sufficiently recovered. Frequent

blood counts are essential to determine optimal dosage and to avoid toxicity. Dose adjustment on the

basis of blood counts at the nadir and day of treatment should be considered.

Hypersensitivity reactions including anaphylaxis have occurred in approximately 2% of patients who

received the IV formulation (see ADVERSE REACTIONS). These reactions usually occur after

multiple courses of treatment. Treatment is symptomatic. The infusion should be terminated immediately,

followed by the administration of volume expanders, pressor agents, corticosteroids, or antihistamines

at the discretion of the physician. If a hypersensitivity reaction occurs, IV or oral melphalan should not

be readministered since hypersensitivity reactions have also been reported with oral melphalan.

Carcinogenesis:

Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and

carcinoma, have been reported in patients with cancer treated with alkylating agents (including

melphalan). Some patients also received other chemotherapeutic agents or radiation therapy. Precise

quantitation of the risk of acute leukemia, myeloproliferative syndrome, or carcinoma is not possible.

Published reports of leukemia in patients who have received melphalan (and other alkylating agents)

suggest that the risk of leukemogenesis increases with chronicity of treatment and with cumulative dose.

In one study, the 10-year cumulative risk of developing acute leukemia or myeloproliferative syndrome

after oral melphalan therapy was 19.5% for cumulative doses ranging from 730 to 9,652 mg. In this

same study, as well as in an additional study, the 10-year cumulative risk of developing acute leukemia

or myeloproliferative syndrome after oral melphalan therapy was less than 2% for cumulative doses

under 600 mg. This does not mean that there is a cumulative dose below which there is no risk of the

induction of secondary malignancy. The potential benefits from melphalan therapy must be weighed on

an individual basis against the possible risk of the induction of a second malignancy.

Adequate and well-controlled carcinogenicity studies have not been conducted in animals. However,

intraperitoneal (IP) administration of melphalan in rats (5.4 to 10.8 mg/m2) and in mice (2.25 to 4.5

mg/m2) 3 times per week for 6 months followed by 12 months post-dose observation produced

peritoneal sarcoma and lung tumors, respectively.

Mutagenesis: Melphalan has been shown to cause chromatid or chromosome damage in humans.

Intramuscular administration of melphalan at 6 and 60 mg/m2 produced structural aberrations of the

chromatid and chromosomes in bone marrow cells of Wistar rats.

Impairment of Fertility: Melphalan causes suppression of ovarian function in premenopausal women,

resulting in amenorrhea in a significant number of patients. Reversible and irreversible testicular

suppression have also been reported.

Pregnancy: Pregnancy Category D. Melphalan may cause fetal harm when administered to a pregnant

woman. While adequate animal studies have not been conducted with IV melphalan, oral (6 to 18

mg/m2/day for 10 days) and IP (18 mg/m2) administration in rats was embryolethal and teratogenic.

Malformations resulting from melphalan included alterations of the brain (underdevelopment,

deformation, meningocele, and encephalocele) and eye (anophthalmia and microphthalmos), reduction of

the mandible and tail, as well as hepatocele (exomphaly). There are no adequate and well-controlled

studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant

while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of

childbearing potential should be advised to avoid becoming pregnant.

PRECAUTIONS

General: In all instances where the use of Melphalan hydrochloride for Injection is considered for

chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of

adverse events. Melphalan should be used with extreme caution in patients whose bone marrow reserve

may have been compromised by prior irradiation or chemotherapy or whose marrow function is

recovering from previous cytotoxic therapy.

Dose reduction should be considered in patients with renal insufficiency receiving IV melphalan. In one

trial, increased bone marrow suppression was observed in patients with BUN levels ≥30 mg/dL. A 50%

reduction in the IV melphalan dose decreased the incidence of severe bone marrow suppression in the

latter portion of this study.

Administration of live vaccines to immunocompromised patients should be avoided.

INFORMATION FOR PATIENTS

Patients should be informed that the major acute toxicities of melphalan are related to bone marrow

suppression, hypersensitivity reactions, gastrointestinal toxicity, and pulmonary toxicity. The major

long-term toxicities are related to infertility and secondary malignancies. Patients should never be

allowed to take the drug without close medical supervision and should be advised to consult their

physicians if they experience skin rash, signs or symptoms of vasculitis, bleeding, fever, persistent

cough, nausea, vomiting, amenorrhea, weight loss, or unusual lumps/masses. Women of childbearing

potential should be advised to avoid becoming pregnant.

LABORATORY TESTS

Periodic complete blood counts with differentials should be performed during the course of treatment

with melphalan. At least 1 determination should be obtained prior to each dose. Patients should be

observed closely for consequences of bone marrow suppression, which include severe infections,

bleeding, and symptomatic anemia (see WARNINGS).

DRUG INTERACTIONS

The development of severe renal failure has been reported in patients treated with a single dose of IV

melphalan followed by standard oral doses of cyclosporine. Cisplatin may affect melphalan kinetics by

inducing renal dysfunction and subsequently altering melphalan clearance. IV melphalan may also reduce

the threshold for BCNU lung toxicity. When nalidixic acid and IV melphalan are given simultaneously,

the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric

patients.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

See WARNINGS section.

PREGNANCY

Teratogenic Effects: Pregnancy Category D: See WARNINGS section.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. IV melphalan should not be given to nursing

mothers.

PEDIATRIC USE

The safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE

Clinical studies of Melphalan hydrochloride for Injection did not include sufficient numbers of subjects

aged 65 and over to determine whether they respond differently from younger subjects. Other reported

clinical experience has not identified differences in responses between the elderly and younger

patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low

end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac

function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

The following information on adverse reactions is based on data from both oral and IV administration of

melphalan as a single agent, using several different dose schedules for treatment of a wide variety of

malignancies.

Hematologic: The most common side effect is bone marrow suppression leading to leukopenia,

thrombocytopenia, and anemia. White blood cell count and platelet count nadirs usually occur 2 to 3

weeks after treatment, with recovery in 4 to 5 weeks after treatment. Irreversible bone marrow failure

has been reported.

Gastrointestinal: Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral

ulceration occur infrequently. Hepatic disorders ranging from abnormal liver function tests to clinical

manifestations such as hepatitis and jaundice have been reported. Hepatic veno-occlusive disease has

been reported.

Hypersensitivity: Acute hypersensitivity reactions including anaphylaxis were reported in 2.4% of 425

patients receiving Melphalan hydrochloride for Injection for myeloma (see WARNINGS). These

reactions were characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia,

bronchospasm, dyspnea, and hypotension. These patients appeared to respond to antihistamine and

corticosteroid therapy. If a hypersensitivity reaction occurs, IV or oral melphalan should not be

readministered since hypersensitivity reactions have also been reported with oral melphalan. Cardiac

arrest has also been reported rarely in association with such reports.

Miscellaneous: Other reported adverse reactions include skin hypersensitivity, skin ulceration at

injection site, skin necrosis rarely requiring skin grafting, maculopapular rashes, vasculitis, alopecia,

hemolytic anemia, allergic reaction, pulmonary fibrosis (including fatal outcomes), and interstitial

pneumonitis. Temporary significant elevation of the blood urea has been seen in the early stages of

therapy in patients with renal damage. Subjective and transient sensation of warmth and/or tingling.

To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-

611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Overdoses resulting in death have been reported. Overdoses, including doses up to 290 mg/m

, have

produced the following symptoms: severe nausea and vomiting, decreased consciousness, convulsions,

muscular paralysis, and cholinomimetic effects. Severe mucositis, stomatitis, colitis, diarrhea, and

hemorrhage of the gastrointestinal tract occur at high doses (>100 mg/m

). Elevations in liver enzymes

and veno-occlusive disease occur infrequently. Significant hyponatremia caused by an associated

inappropriate secretion of ADH syndrome has been observed. Nephrotoxicity and adult respiratory

distress syndrome have been reported rarely. The principal toxic effect is bone marrow suppression.

Hematologic parameters should be closely followed for 3 to 6 weeks. An uncontrolled study suggests

that administration of autologous bone marrow or hematopoietic growth factors (i.e., sargramostim,

filgrastim) may shorten the period of pancytopenia. General supportive measures together with

appropriate blood transfusions and antibiotics should be instituted as deemed necessary by the

physician. This drug is not removed from plasma to any significant degree by hemodialysis or

hemoperfusion. A pediatric patient survived a 254-mg/m2 overdose treated with standard supportive

care.

DOSAGE & ADMINISTRATION

The usual IV dose is 16 mg/m

. Dosage reduction of up to 50% should be considered in patients with

renal insufficiency (BUN ≥30 mg/dL) (see PRECAUTIONS: General). The drug is administered as a

single infusion over 15 to 20 minutes. Melphalan is administered at 2-week intervals for 4 doses, then,

after adequate recovery from toxicity, at 4-week intervals. Available evidence suggests about one third

to one half of the patients with multiple myeloma show a favorable response to the drug. Experience

with oral melphalan suggests that repeated courses should be given since improvement may continue

slowly over many months, and the maximum benefit may be missed if treatment is abandoned prematurely.

Dose adjustment on the basis of blood cell counts at the nadir and day of treatment should be considered.

Administration Precautions: As with other toxic compounds, caution should be exercised in handling

and preparing the solution of Melphalan hydrochloride. Skin reactions associated with accidental

exposure may occur. The use of gloves is recommended. If the solution of Melphalan hydrochloride

contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several

guidelines on this subject have been published.

There is no general agreement that all of the

procedures recommended in the guidelines are necessary or appropriate.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to

administration whenever solution and container permit. If either occurs, do not use this product.

Care should be taken to avoid possible extravasation of melphalan and in cases of poor peripheral

venous access, consideration should be given to use of a central venous line (see WARNINGS).

Preparation for Administration/Stability

1. Melphalan hydrochloride for Injection must be reconstituted by rapidly injecting 10 mL of the

supplied diluent directly into the vial of lyophilized powder using a sterile needle (20-gauge or larger

needle diameter) and syringe. Immediately shake vial vigorously until a clear solution is obtained. This

provides a 5-mg/mL solution of melphalan. Rapid addition of the diluent followed by immediate

vigorous shaking is important for proper dissolution.

2. Immediately dilute the dose to be administered in 0.9% Sodium Chloride Injection, USP, to a

concentration not greater than 0.45 mg/mL.

3. Administer the diluted product over a minimum of 15 minutes.

4. Complete administration within 60 minutes of reconstitution.

The time between reconstitution/dilution and administration of Melphalan hydrochloride should

be kept to a minimum because reconstituted and diluted solutions of Melphalan hydrochloride

are unstable. Over as short a time as 30 minutes, a citrate derivative of melphalan has been detected in

reconstituted material from the reaction of Melphalan hydrochloride with Sterile Diluent for Melphalan

hydrochloride. Upon further dilution with saline, nearly 1% label strength of melphalan hydrolyzes

every 10 minutes. A precipitate forms if the reconstituted solution is stored at 5°C. DO NOT

REFRIGERATE THE RECONSTITUTED PRODUCT.

HOW SUPPLIED

Melphalan Hydrochloride for Injection is supplied as follows:

NDC

Melphalan Hydrochloride for Injection (Kit)

Package Factor

72266-128-01

Single-Dose Vial of Melphalan Hydrochloride for Injection

10 mL Vial of Sterile Diluent

1 vial per carton

1 vial per carton

Each carton contains one single-dose clear glass vial of lyophilized melphalan hydrochloride

equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.

Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Protect from light.

REFERENCES

1. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in

Healthcare Settings. U.S. Department of Health and Human Services, Public Health Service. Centers

for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS

(NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure

to Hazardous Drugs. OSHA, 1999.http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.htm

3. 3.American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling

Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193

4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and Biotherapy Guidelines and

Recommendations for Practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.

Distributed by:

Fosun Pharma USA Inc.

Princeton, NJ 08540

Made in India

July 2019

LEA-020245-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Melphalan Hydrochloride for Injection

melphalan-50mg-carton

NDC 72266-128-01

MELPHALAN HYDROCHLORIDE

melphalan hydrochloride kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:7226 6 -128

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7226 6 -128 -0 1

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 9 /23/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 VIAL, SINGLE-DOSE

10 mL

Pa rt 2

1 VIAL, SINGLE-USE

10 mL

Part 1 of 2

MELPHALAN HYDROCHLORIDE

melphalan hydrochloride injection, powder, for solution

Product Information

Ite m Code (Source )

NDC:7226 6 -144

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MELPHALAN HYDRO CHLO RIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9 510 P)

MELPHALAN

50 mg in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7226 6 -144-

10 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 8 26

0 9 /23/20 19

Part 2 of 2

DILUENT FOR MELPHALAN

diluent for melphalan solution

Product Information

Ite m Code (Source )

NDC:7226 6 -145

Route of Administration

INTRAVENOUS

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Fosun Pharma USA Inc

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7226 6 -145-

10 mL in 1 VIAL, SINGLE-USE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 8 26

0 9 /23/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 8 26

0 9 /23/20 19

Labeler -

Fosun Pharma USA Inc (080920998)

Revised: 9/2019

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