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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 209846


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NDA 209846 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Alembic, Amneal, Encube, Quagen, Solaris Pharma Corp, Zydus Lifesciences, 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, Chartwell Rx, Encube Ethicals, Endo Operations, Fougera Pharms Inc, G And W Labs Inc, Novast Labs, Padagis Us, Pai Holdings Pharm, Taro Pharm Inds, Vintage Pharms, Xttrium Labs Inc, Epic Pharma Llc, Actavis Labs Ut Inc, Glenmark Speclt, Mylan Pharms Inc, Zydus Pharms, Actavis Mid Atlantic, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in eighty-nine NDAs. It is available from twenty-one 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. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 209846
Tradename:CLINDAMYCIN PHOSPHATE
Applicant:Chartwell Rx
Ingredient:clindamycin phosphate
Patents:0
Pharmacology for NDA: 209846
Suppliers and Packaging for NDA: 209846
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 209846 ANDA A-S Medication Solutions 50090-5779 50090-5779-0 1 BOTTLE, WITH APPLICATOR in 1 CARTON (50090-5779-0) / 60 mL in 1 BOTTLE, WITH APPLICATOR
CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION;TOPICAL 209846 ANDA Glasshouse Pharmaceuticals Limited Canada 71428-003 71428-003-30 1 BOTTLE in 1 CARTON (71428-003-30) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrengthEQ 1% BASE
Approval Date:Feb 8, 2018TE:ATRLD:No

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