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Boehringer Ingelheim
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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 210778

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NDA 210778 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro Pharm Inds Ltd, Fougera Pharms, Amneal, Encube, Solaris Pharma Corp, Taro Pharms, Abraxis Pharm, Almaject, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, Igi Labs Inc, Loch, Marsam Pharms Llc, Rising, Sagent Pharms Inc, Solopak, Teva Parenteral, Watson Labs, Boca Pharma Llc, Cadila, Encube Ethicals, Fougera Pharms Inc, G And W Labs Inc, Glasshouse Pharms, Novast Labs, Padagis Us, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Wockhardt Bio Ag, Akorn, Actavis Labs Ut Inc, Anda Repository, Glenmark Pharms, Mylan Pharms Inc, Taro, Tolmar, Zydus Pharms, Actavis Mid Atlantic, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in eighty-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 210778
Applicant:Glenmark Pharms Ltd
Ingredient:clindamycin phosphate
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength1%
Approval Date:Sep 20, 2021TE:ATRLD:No

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