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Serving leading biopharmaceutical companies globally:

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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064160

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NDA 064160 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Perrigo Uk Finco, Fougera Pharms, Abraxis Pharm, Alvogen Inc, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Igi Labs Inc, Loch, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Boca Pharma Llc, Fougera Pharms Inc, G And W Labs Inc, Novast Labs Ltd, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt, Akorn, Actavis Labs Ut Inc, Mylan Pharms Inc, Perrigo Israel, 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-three 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 064160
Tradename:CLINDAMYCIN PHOSPHATE
Applicant:Fougera Pharms
Ingredient:clindamycin phosphate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 064160
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 064160
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE clindamycin phosphate GEL;TOPICAL 064160 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0202 0168-0202-30 1 TUBE in 1 CARTON (0168-0202-30) > 30 g in 1 TUBE
CLINDAMYCIN PHOSPHATE clindamycin phosphate GEL;TOPICAL 064160 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0202 0168-0202-60 1 TUBE in 1 CARTON (0168-0202-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 1% BASE
Approval Date:Jan 28, 2000TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Mallinckrodt
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AstraZeneca
US Army
Novartis
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