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Generated: November 17, 2017

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Details for New Drug Application (NDA): 065049

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NDA 065049 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Alvogen Inc, Watson Labs, Wockhardt, Loch, West-ward Pharms Int, Bristol Myers Squibb, Sagent Pharms, Novast Labs Ltd, G And W Labs Inc, Marsam Pharms Llc, Akorn, Solopak, Igi Labs Inc, Vintage Pharms, Fougera Pharms, Teva Parenteral, Boca Pharma Llc, Teligent Pharma Inc, Fresenius Kabi Usa, Abraxis Pharm, Mylan Labs Ltd, Perrigo New York, Fougera Pharms Inc, Bedford, Taro Pharm Inds, Perrigo Uk Finco, Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, Tolmar, Actavis Mid Atlantic, Baxter Hlthcare Corp, Akorn Inc, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-eight NDAs. It is available from twenty-two suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for 065049

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065049

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 065049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
SWAB;TOPICAL 065049 ANDA Medimetriks Pharmaceuticals, Inc. 43538-170 43538-170-69 69 SWAB in 1 JAR (43538-170-69)
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
SWAB;TOPICAL 065049 ANDA Medimetriks Pharmaceuticals, Inc. 43538-171 43538-171-69 1 JAR in 1 KIT (43538-171-69) > 69 SWAB in 1 JAR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SWAB;TOPICALStrengthEQ 1% BASE
Approval Date:May 25, 2000TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
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Queensland Health

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