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Generated: December 17, 2018

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Details for New Drug Application (NDA): 065067

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NDA 065067 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, Glasshouse Pharms, Novast Labs, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt Bio Ag, Zydus Pharms Usa Inc, Akorn, Actavis Labs Ut Inc, Mylan Pharms Inc, Perrigo Israel, Taro, Taro Pharms, Tolmar, Actavis Mid Atlantic, Baxter Hlthcare Corp, Akorn Inc, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in sixty-three 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-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 065067
Tradename:CLINDAMYCIN PHOSPHATE
Applicant:Fougera Pharms
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065067
Suppliers and Packaging for NDA: 065067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE clindamycin phosphate LOTION;TOPICAL 065067 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0203 0168-0203-60 1 BOTTLE in 1 CARTON (0168-0203-60) > 60 mL in 1 BOTTLE
CLINDAMYCIN PHOSPHATE clindamycin phosphate LOTION;TOPICAL 065067 ANDA PharmaDerm, A division of Nycomed US Inc. 0462-0391 0462-0391-60 60 mL in 1 BOTTLE (0462-0391-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrengthEQ 1% BASE
Approval Date:Jan 31, 2002TE:ABRLD:No

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