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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064159

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NDA 064159 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Alvogen Inc, Watson Labs, Wockhardt, Loch, West-ward Pharms Int, Bristol Myers Squibb, Sagent Pharms, Ingenus Pharms Llc, 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, 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, Celerity Pharms, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-six 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-two 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 NDA: 064159

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

Pharmacology for NDA: 064159

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 064159

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
SOLUTION;TOPICAL 064159 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0201 0168-0201-30 1 BOTTLE in 1 CARTON (0168-0201-30) > 30 mL in 1 BOTTLE
CLINDAMYCIN PHOSPHATE
clindamycin phosphate
SOLUTION;TOPICAL 064159 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0201 0168-0201-60 1 BOTTLE in 1 CARTON (0168-0201-60) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrengthEQ 1% BASE
Approval Date:Jun 5, 1997TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Chubb
Cipla
Healthtrust
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Colorcon
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Harvard Business School

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