FINACEA- azelaic acid gel

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

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Active ingredient:
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)
Available from:
A-S Medication Solutions
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. None. There are no adequate and well-controlled studies in pregnant women. Therefore, FINACEA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. E
Product summary:
Product: 50090-4473 NDC: 50090-4473-0 50 g in a TUBE / 1 in a CARTON
Authorization status:
New Drug Application
Authorization number:
50090-4473-0

FINACEA- azelaic acid gel

A-S Medication Solutions

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use FINACEA Gel safely and effectively. See

full prescribing information for FINACEA Gel.

FINACEA (azelaic acid) Gel, 15% for topical use

Initial U.S. Approval: 1995

INDICATIONS AND USAGE

FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to

moderate rosacea. Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been

evaluated. (1)

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

Gel, 15% (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity: In case of known hypersensitivity to any component of the gel, avoid the use of FINACEA Gel. If

hypersensitivity develops during treatment, discontinue FINACEA Gel and institute appropriate therapy. (5.1)

Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of

treatment with FINACEA Gel. If sensitivity or severe irritation develops and persists, discontinue treatment and

institute appropriate therapy. (5.2)

Hypopigmentation: Isolated cases of hypopigmentation occurred after azelaic acid use. Monitor patients with dark

complexion for early signs of hypopigmentation (5.2)

Eye and Mucous Membrane Irritation: FINACEA Gel has been reported to cause irritation of the eyes. Therefore, avoid

contact with the eyes and mucous membranes. (5.3)

Exacerbation of Asthma: Consult a physician if asthma is exacerbated with FINACEA Gel use. (5.4)

ADVERSE REACTIONS

The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%)

and erythema/irritation (4%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-

FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

®

®

Apply a thin layer of FINACEA Gel twice daily to affected area(s). (2)

Use only very mild soaps or soapless cleansing lotion before applying FINACEA Gel. (2)

Cosmetics may be applied after the application of FINACEA Gel has dried. (2)

Avoid spicy foods, thermally hot foods and drinks, alcoholic beverages. (2)

Not for oral, ophthalmic or intravaginal use. (2)

5.2 Skin Reactions

5.3 Eye and Mucous Membranes Irritation

5.4 Exacerbation of Asthma

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of the inflammatory papules and

pustules of mild to moderate rosacea. Although some reduction of erythema which was present in

patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of

erythema in rosacea in the absence of papules and pustules has not been evaluated.

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of FINACEA

Sections or subsections omitted from the full prescribing information are not listed.

Apply and gently massage a thin layer of FINACEA Gel into the affected areas on the face twice

daily (morning and evening).

Use only very mild soaps or soapless cleansing lotion before application of FINACEA Gel.

Cosmetics may be applied after the application of FINACEA Gel has dried.

Avoid the use of occlusive dressings or wrappings.

Instruct patients to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages.

Patients should be reassessed if no improvement is observed upon completing 12 weeks of

therapy.

Not for oral, ophthalmic or intravaginal use.

Gel contains 0.15 gm of azelaic acid (15% w/w).

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea,

urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of FINACEA Gel in patients with known hypersensitivity to any component of the gel. If

hypersensitivity develops during treatment, discontinue FINACEA Gel and institute appropriate therapy.

5.2 Skin Reactions

Skin irritation (i.e. pruritus, burning or stinging) may occur during use of FINACEA Gel, usually during

the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue

treatment and institute appropriate therapy.

There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has

not been well studied in patients with dark complexion, monitor these patients for early signs of

hypopigmentation.

5.3 Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in

contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation

persists [see Adverse Reactions (6.2)].

5.4 Exacerbation of Asthma

Worsening of asthma has been reported in patients using azelaic acid formulations including FINACEA

Gel. Consult a physician if asthma is exacerbated with use of FINACEA Gel.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored

in 788 subjects who used twice-daily FINACEA Gel for 12 weeks (N=333) or 15 weeks (N=124), or

the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse

events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and

erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning,

stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4%

(24/124) for FINACEA Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.

Table 1: Adverse Events Occurring in ≥1% of Subjects in the Rosacea Trials by Treatment

Group and Maximum Intensity*

FINACEA Gel, 15%

Vehicle

N=457

(100%)

N=331

(100%)

Mild

N=99

(22%)

Moderate

N=61

(13%)

Severe

N=27

(6%)

Mild

N=46

(14%)

Moderate

N=30

(9%)

Severe

N=5

(2%)

Burning/stinging/tingling

71 (16%)

42 (9%)

17 (4%)

8 (2%)

6 (2%)

2 (1%)

Pruritus

29 (6%)

18 (4%)

5 (1%)

9 (3%)

6 (2%)

0 (0%)

Scaling/dry skin/xerosis

21 (5%)

10 (2%)

5 (1%)

31 (9%)

14 (4%)

1 (<1%)

Erythema/irritation

6 (1%)

7 (2%)

2 (<1%)

8 (2%)

4 (1%)

2 (1%)

Contact dermatitis

2 (<1%)

3 (1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

Edema

3 (1%)

2 (<1%)

0 (0%)

3 (1%)

0 (0%)

0 (0%)

Acne

3 (1%)

1 (<1%)

0 (0%)

1 (<1%)

0 (0%)

0 (0%)

In patients using azelaic acid formulations, the following adverse events have been reported: worsening

of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of

keratosis pilaris) and exacerbation of recurrent herpes labialis.

Local Tolerability Studies

FINACEA Gel and its vehicle caused irritant reactions at the application site in human dermal safety

studies. FINACEA Gel caused significantly more irritation than its vehicle in a cumulative irritation

study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this

improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were

reported in human dermal safety studies.

6.2 Post-Marketing Experience

The following adverse reactions have been identified post approval of FINACEA Gel. Because these

reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate the frequency or establish a causal relationship to drug exposure:

Eyes: iridocyclitis upon accidental exposure of the eyes to FINACEA Gel

Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.

Respiratory: worsening of asthma, dyspnea, wheezing,

7 DRUG INTERACTIONS

There have been no formal studies of the interaction of FINACEA Gel with other drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. Therefore, FINACEA Gel

should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15%

gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and

cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three

*Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms

may exceed the number of subjects with at least 1 cutaneous adverse event.

animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid

that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162

times the maximum recommended human dose (MRHD) based on body surface area (BSA)], rabbits

given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys given

500 mg/kg/day (65 times the MRHD based on BSA) azelaic acid. No teratogenic effects were observed

in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys.

An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered

from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day.

Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on

BSA) that generated some maternal toxicity. In addition, slight disturbances in the post-natal

development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and

2500 mg/kg/day; 32 and 162 times the MRHD based on BSA). No effects on sexual maturation of the

fetuses were noted in this study.

8.3 Nursing Mothers

It is not known whether azelaic acid is excreted in human milk; however, in vitro studies using

equilibrium dialysis were conducted to assess the potential for human milk partitioning. The studies

demonstrated that, at an azelaic acid concentration of 25 µg/mL, the milk/plasma distribution coefficient

was 0.7 and the milk/buffer distribution was 1.0. These data indicate that passage of drug into maternal

milk may occur. Since less than 4% of a topically applied dose of 20% azelaic acid cream is

systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a

significant change from baseline azelaic acid levels in the milk. Nevertheless, a decision should be

made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to

the mother.

8.4 Pediatric Use

Safety and effectiveness of FINACEA Gel in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects.

11 DESCRIPTION

FINACEA (azelaic acid) Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring

saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular

formula for azelaic acid is C H O . It has the following structure:

Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly

soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.

FINACEA Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm

azelaic acid (15%w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium

EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol,

purified water, and sodium hydroxide to adjust pH.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.

12.2 Pharmacodynamics

The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown.

12.3 Pharmacokinetics

The percutaneous absorption of azelaic acid after topical application of FINACEA Gel could not be

reliably determined. Mean plasma azelaic acid concentrations in rosacea subjects treated with

FINACEA Gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are

within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea subjects treated with

vehicle only. This indicates that FINACEA Gel does not increase plasma azelaic acid concentration

beyond the range derived from nutrition and endogenous metabolism.

In vitro and human data suggest negligible cutaneous metabolism of

H-azelaic acid after topical

application of 20% azelaic acid cream. Azelaic acid is mainly excreted unchanged in the urine, but

undergoes some ß-oxidation to shorter chain dicarboxylic acids.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of

azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA Gel

and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC

animals with papillomas at the treatment site. No statistically significant increase in the number of

animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily

application. After twice daily application, FINACEA Gel and the gel vehicle induced a statistically

significant increase in the number of male animals with papillomas at the treatment site when compared

to untreated males. This suggests that the positive effect may be associated with the vehicle application.

The clinical relevance of the findings in animals to humans is not clear.

Azelaic acid was not mutagenic or clastogenic in a battery of in vitro [Ames assay, HGPRT in V79 cells

(Chinese hamster lung cells), and chromosomal aberration assay in human lymphocytes] and in vivo

(dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.

Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the MRHD based on

BSA) did not affect fertility or reproductive performance in male or female rats.

14 CLINICAL STUDIES

FINACEA Gel was evaluated for the treatment of mild to moderate papulopustular rosacea in two

multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials having identical

protocols and involving a total of 664 (active: 333; vehicle: 331) subjects aged 21 to 86 years (mean age

= 49). Overall, 92.5% of subjects were Caucasian and 73% of subjects were female. Enrolled subjects

had mild to moderate rosacea with a mean lesion count of 18 (range 8 to 60) inflammatory papules and

pustules. The following subjects were excluded: a) those without papules and pustules; b) those with

nodules, rhinophyma, or ocular involvement and c) those with a history of hypersensitivity to propylene

glycol or to any other ingredients of the study drug. FINACEA Gel or its vehicle were to be applied

twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea

and/or evaluability was to be used during the studies. Subjects were instructed to avoid spicy foods,

thermally hot food/drink and alcoholic beverages during the study. Subjects were also instructed to use

only very mild soaps or soapless cleansing lotion for facial cleansing.

The primary efficacy endpoints included both 1) change from baseline in inflammatory lesion counts as

well as 2) success defined as a score of “clear” or “minimal” with at least a 2-step reduction from

baseline on the Investigator’s Global Assessment (IGA), defined as follows below:

CLEAR:

No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia

MINIMAL:

Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia

MILD:

Few papules and/or pustules; mild erythema; mild to moderate telangiectasia

MILD TO MODERATE:

Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia

MODERATE:

Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia

MODERATE TO SEVERE:

Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate

degree of telangiectasia

SEVERE:

Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or

severe erythema; moderate or severe telangiectasia

Primary efficacy assessment was based on the “intent-to-treat” (ITT) population with the “last

observation carried forward” (LOCF).

Both trials demonstrated a statistically significant difference in favor of FINACEA Gel over its vehicle

in both reducing the number of inflammatory papules and pustules associated with rosacea (Table 2) as

well as demonstrating success on the IGA in the ITT-LOCF population at the end of treatment.

Table 2: Inflammatory Papules and Pustules (ITT population)*

*ITT population with last observation carried forward (LOCF)

Study One

FINACEA Gel,

15%

N=164

Study One

VEHICLE

N=165

Study Two

FINACEA Gel,

15%

N=167

Study Two

VEHICLE

N=166

Mean Lesion Count

Baseline

17.5

17.6

17.9

18.5

End of Treatment

10.5

12.1

Mean Percent

Reduction End of

Treatment

57.9%

39.9%

50.0%

38.2%

Although some reduction of erythema which was present in subjects with papules and pustules of

rosacea occurred in clinical trials, efficacy for treatment of erythema in rosacea in the absence of

papules and pustules has not been evaluated.

FINACEA Gel was superior to the vehicle with regard to success based on the IGA of rosacea on a 7-

point static score at the end of treatment (ITT population; Table 3).

Table 3: Investigator’s Global Assessment at the End of Treatment*

Study One

Study One

Study Two

Study Two

*ITT population with last observation carried forward (LOCF)

FINACEA Gel,

15%

N=164

VEHICLE

N=165

FINACEA Gel,

15%

N=167

VEHICLE

N=166

Clear, Minimal or

Mild at End of

Treatment

(% of Subjects)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4473

NDC: 50090-4473-0 50 g in a TUBE / 1 in a CARTON

17 PATIENT COUNSELING INFORMATION

Inform patients using FINACEA Gel of the following information and instructions:

For external use only.

Before applying FINACEA Gel, cleanse affected area(s) with a very mild soap or a soapless

cleansing lotion and pat dry with a soft towel.

Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.

Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel does come in

contact with the eyes, wash the eyes with large amounts of water and consult their healthcare

providers if eye irritation persists.

Wash hands immediately following application of FINACEA Gel.

Cosmetics may be applied after the application of FINACEA Gel has dried.

Avoid the use of occlusive dressings or wrappings.

Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA Gel, usually

during the first few weeks of treatment. If irritation is excessive or persists, or allergic reactions

occur, discontinue use and consult your physician.

If allergic reactions occur, discontinue use and consult their healthcare providers.

Advise patients to report any worsening of asthma to their healthcare providers.

Report abnormal changes in skin color to their healthcare providers.

To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing.

These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or

alcoholic beverages.

FINACEA Gel comes in a tube:

-Tube instructions: Remove the cap before use. Squeeze the tube to dispense a small amount of

FINACEA Gel.

FINACEA is a registered trademark of LEO Pharma A/S.

© 2019, LEO Pharma Inc. All rights reserved.

Manufactured for:

LEO Pharma Inc., Madison, NJ 07940 USA

Manufactured by:

LEO Pharma Manufacturing Italy S.r.l., Via E Schering 21, 20090 Segrate, Milano, Italy

Storage

Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room

Temperature].

azelaic acid

FINACEA

azelaic acid gel

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 0 9 0 -4473(NDC:50 222-50 5)

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)

AZELAIC ACID

0 .15 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

1,2 -DIARACHIDO YL-SN-GLYCERO -3 -PHO SPHO CHO LINE (UNII: HE0 P2D9 ZLS)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PO LYACRYLIC ACID ( 2 50 0 0 0 MW) (UNII: 9 G2MAD7J6 W)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

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

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

A-S Medication Solutions

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -4473-0

1 in 1 CARTON

0 8 /20 /20 19

1

50 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 21470

12/24/20 0 2

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -4473)

Revised: 7/2020

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