CLINDAMYCIN HYDROCHLORIDE- clindamycin hydrochloride capsule

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

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Active ingredient:
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED  WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endomet
Product summary:
Product: 71335-1274 NDC: 71335-1274-1 30 CAPSULE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
71335-1274-1

CLINDAMYCIN HYDROCHLORIDE- clindamycin hydrochloride capsule

Bryant Ranch Prepack

----------

Clindamycin Hydrochloride Capsules, USP

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin

hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or

prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all

antibacterial agents, including clindamycin hydrochloride and may range in severity from

mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of

the colon, leading to overgrowth of C. difficile.

Because clindamycin hydrochloride therapy has been associated with severe colitis which

may end fatally, it should be reserved for serious infections where less toxic antimicrobial

agents are inappropriate, as described in the INDICATIONS AND USAGE section. It

should not be used in patients with nonbacterial infections such as most upper respiratory

tract infections.

C. difficile produces toxins A and B, which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as

these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two

months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile

may need to be discontinued. Appropriate fluid and electrolyte management, protein

supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be

instituted as clinically indicated.

DESCRIPTION

Clindamycin hydrochloride, USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a

semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent

compound lincomycin.

Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or

300 mg of clindamycin.

Inactive ingredients: anhydrous lactose, magnesium stearate, starch (corn) and talc. The capsule shells

contain: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The

150 mg capsule shell also contains black iron oxide and yellow iron oxide.

The structural formula is represented below:

H CIN O SHCl

M.W. 461.44

The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-

methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside

monohydrochloride.

CLINICAL PHARMACOLOGY

Human Pharmacology

Abs orption

Pharmacokinetic studies with a 150 mg oral dose of clindamycin hydrochloride in 24 normal adult

volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak

serum concentration of 2.50 mcg/mL was reached in 45 minutes; serum concentrations averaged 1.51

mcg/mL at 3 hours and 0.70 mcg/mL at 6 hours. Absorption of an oral dose is virtually complete (90%),

and the concomitant administration of food does not appreciably modify the serum concentrations; serum

concentrations have been uniform and predictable from person to person and dose to dose.

Pharmacokinetic studies following multiple doses of clindamycin hydrochloride for up to 14 days show

no evidence of accumulation or altered metabolism of drug. Doses of up to 2 grams of clindamycin per

day for 14 days have been well tolerated by healthy volunteers, except that the incidence of

gastrointestinal side effects is greater with the higher doses.

Dis tribution

Concentrations of clindamycin in the serum increased linearly with increased dose. Serum

concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at

least six hours following administration of the usually recommended doses. Clindamycin is widely

distributed in body fluids and tissues (including bones). No significant concentrations of clindamycin

are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

Metabolis m

In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly

metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form

clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin.

Excretion

The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the

urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites.

Specific Populations

Patients with Renal Impairment

Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function.

Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Elderly Patients

Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years)

indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life,

volume of distribution, and area under the serum concentration-time curve) after IV administration of

clindamycin phosphate. After oral administration of clindamycin hydrochloride, the average elimination

half-life is increased to approximately 4.0 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2

hours (range 2.1 to 4.2 h) in younger adults. The extent of absorption, however, is not different between

age groups and no dosage alteration is necessary for the elderly with normal hepatic function and

normal (age-adjusted) renal function .

Microbiology

Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the

ribosome. Clindamycin is bacteriostatic.

Resistance

Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal

RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for

these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides,

macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates

of macrolide-resistant bacteria. Macrolide-resistant isolates of staphylococci and beta-hemolytic

streptococci should be screened for induction of clindamycin resistance using the D-zone test.

Antimicrobial Activity

Clindamycin has been shown to be active against most of the isolates of the following microorganisms,

both

in vitro and in clinical infections [see INDICATIONS AND USAGE (1)]:

Gram-positive bacteria

Staphylococcus aureus (methicillin-susceptible strains)

Streptococcus pneumoniae (penicillin-susceptible strains)

Streptococcus pyogenes

Anaerobic bacteria

Clostridium perfringens

Fusobacterium necrophorum

Fusobacterium nucleatum

Peptostreptococcus anaerobius

Prevotella melaninogenica

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent

of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to

the susceptible breakpoint for clindamycin against isolates of a similar genus or organism group.

However, the efficacy of clindamycin in treating clinical infections due to these bacteria has not been

established in adequate and well-controlled clinical trials.

Gram-positive bacteria

Staphylococcus epidermidis (methicillin-susceptible strains)

Streptococcus agalactiae

Streptococcus anginosus

Streptococcus mitis

Streptococcus oralis

Anaerobic bacteria

Actinomyces israelii

Clostridium clostridioforme

Eggerthella lenta

Finegoldia (Peptostreptococcus) magna

Micromonas (Peptostreptococcus) micros

Prevotella bivia

Prevotella intermedia

Propionibacterium acnes

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods

and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

INDICATIONS AND USAGE

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of

streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic

patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin,

the physician should consider the nature of the infection and the suitability of less toxic alternatives

(e.g., erythromycin).

Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung

abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as

peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the

normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis,

nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.

Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.

Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.

Pneumococci: Serious respiratory tract infections.

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility

to clindamycin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin

hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or

prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When

culture and susceptibility information are available, they should be considered in selecting or modifying

antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may

contribute to the empiric selection of therapy.

CONTRAINDICATIONS

Clindamycin hydrochloride is contraindicated in individuals with a history of hypersensitivity to

preparations containing clindamycin or lincomycin.

WARNINGS

See BOXED WARNING.

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial

agents, including clindamycin hydrochloride, and may range in severity from mild diarrhea to fatal

colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth

of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin

producing strains of C. difficile cause increased morbidity and mortality, as these infections can be

refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful

medical history is necessary since CDAD has been reported to occur over two months after the

administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to

be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic

treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Anaphylactic and Severe Hypersensitivity Reactions

Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS).

Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis

(TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson

syndrome (SJS), some with fatal outcome, have been reported (see ADVERSE REACTIONS).

In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently

and institute appropriate therapy.

A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

Usage in Meningitis – Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the

drug should not be used in the treatment of meningitis.

PRECAUTIONS

General

Review of experience to date suggests that a subgroup of older patients with associated severe illness

may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be

carefully monitored for change in bowel frequency.

Clindamycin hydrochloride should be prescribed with caution in individuals with a history of

gastrointestinal disease, particularly colitis.

Clindamycin hydrochloride should be prescribed with caution in atopic individuals.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

The use of clindamycin hydrochloride occasionally results in overgrowth of nonsusceptible organisms

– particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated

by the clinical situation.

Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with

moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it

was postulated from studies that when given every eight hours, accumulation should rarely occur.

Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic

liver enzyme determinations should be made when treating patients with severe liver disease.

Prescribing clindamycin hydrochloride in the absence of a proven or strongly suspected bacterial

infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk

of the development of drug-resistant bacteria.

Information for Patients

Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride should only

be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When

clindamycin hydrochloride is prescribed to treat a bacterial infection, patients should be told that

although it is common to feel better early in the course of therapy, the medication should be taken

exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the

effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop

resistance and will not be treatable by clindamycin hydrochloride or other antibacterial drugs in the

future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is

discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody

stools (with or without stomach cramps and fever) even as late as two or more months after having taken

the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Laboratory Tests

During prolonged therapy, periodic liver and kidney function tests and blood counts should be

performed.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of

other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving

such agents.

Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major

metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors

of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these

isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4

inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as

rifampicin, monitor for loss of effectiveness.

In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or

CYP2D6 and only moderately inhibits CYP3A4.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed with clindamycin to evaluate carcinogenic

potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella

reversion test. Both tests were negative.

Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest

recommended adult human dose based on mg/m ) revealed no effects on fertility or mating ability.

Pregnancy: Teratogenic effects

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and

third trimesters, has not been associated with an increased frequency of congenital abnormalities.

Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no

adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.

Because animal reproduction studies are not always predictive of the human response, this drug should

be used during pregnancy only if clearly needed.

Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day

(3.2 and 1.6 times the highest recommended adult human dose based on mg/m , respectively) or

subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended

adult human dose based on mg/m , respectively) revealed no evidence of teratogenicity.

Nursing Mothers

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. Clindamycin

has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or

intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding,

but an alternate drug may be preferred. Monitor the infant for possible adverse effects on the

gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool

indicating possible antibiotic-associated colitis.

The developmental and health benefits of breastfeeding should be considered along with the mother's

clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin

or from the underlying maternal condition.

Pediatric Use

When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years),

appropriate monitoring of organ system functions is desirable.

Geriatric Use

Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to

determine whether they respond differently from younger patients. However, other reported clinical

experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridium difficile) seen in

association with most antibiotics occur more frequently in the elderly (>60 years) and may be more

severe. These patients should be carefully monitored for the development of diarrhea.

Pharmacokinetic studies with clindamycin have shown no clinically important differences between

young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after

oral or intravenous administration.

ADVERSE REACTIONS

The following reactions have been reported with the use of clindamycin.

Infections and Infestations:

Clostridium difficile colitis

Gas trointes tinal:

Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see

BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after

antibacterial treatment (see WARNINGS). Esophageal ulcer has been reported. An unpleasant or

metallic taste has been reported after oral administration.

Hypersensitivity Reactions:

Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently

reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during

drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome,

have been reported (see WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP),

erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic

reaction and hypersensitivity have also been reported.

Skin and Mucous Membranes:

Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported. (See

Hypersensitivity Reactions.)

Liver:

Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Renal:

Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction

as evidenced by azotemia, oliguria, and/or proteinuria has been observed.

Hematopoietic:

Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and

thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy

could be made in any of the foregoing.

Immune System:

Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Mus culos keletal:

Cases of polyarthritis have been reported.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-

800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

OVERDOSAGE

Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or

subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were

observed.

Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

DOSAGE AND ADMINISTRATION

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see

BOXED WARNING).

Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6

hours.

Pediatric Patients (for children who are able to swallow capsules): Serious infections – 8 to 16

mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections – 16 to 20

mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.

To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken

with a full glass of water.

Clindamycin hydrochloride capsules are not suitable for children who are unable to swallow them

whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the

clindamycin palmitate oral solution in some cases.

Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in

clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment

with clindamycin hydrochloride capsules.

In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

HOW SUPPLIED

Product: 71335-1274

NDC: 71335-1274-1 30 CAPSULE in a BOTTLE

REFERENCES

1. Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged

Population. Upjohn TR 8147-82-9122-021, December 1982.

This product’s label may have been updated. For current full prescribing information, please visit

www.actavis.com.

Manufactured by:

Watson Pharma Private Limited

Verna, Salcette Goa 403 722 INDIA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Rev. B 10/2018

CLINDAMYCIN HCL 300MG CAPS.

CLINDAMYCIN HYDROCHLORIDE

clindamycin hydrochloride capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:71335-1274(NDC:0 59 1-29 32)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength Strength

CLINDAMYCIN HYDRO CHLO RIDE (UNII: T20 OQ1YN1W) (CLINDAMYCIN - UNII:3U0 2EL437C)

CLINDAMYCIN

30 0 mg

Inactive Ingredients

Bryant Ranch Prepack

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

PINK (o paque)

S core

no sco re

S hap e

CAPSULE

S iz e

25mm

Flavor

Imprint Code

DAN;3120

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71335-1274-1

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

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 30 8 3

0 9 /0 9 /20 14

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(71335-1274) , RELABEL(71335-1274)

Revised: 8/2019

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