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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 090109


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NDA 090109 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Glenmark Pharms Ltd, Padagis Israel, Taro, Fougera Pharms, Amneal, Encube, 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, 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 Pharms, Mylan Pharms Inc, Zydus Pharms, Actavis Mid Atlantic, Baxter Hlthcare Corp, Sandoz Inc, Abbott Labs, and Baxter Hlthcare, and is included in eighty-seven 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 090109
Tradename:CLINDAMYCIN PHOSPHATE
Applicant:Sagent Pharms Inc
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090109
Suppliers and Packaging for NDA: 090109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 090109 ANDA Sagent Pharmaceuticals 25021-115 25021-115-02 25 VIAL in 1 CARTON (25021-115-02) / 2 mL in 1 VIAL
CLINDAMYCIN PHOSPHATE clindamycin phosphate INJECTABLE;INJECTION 090109 ANDA Sagent Pharmaceuticals 25021-115 25021-115-04 25 VIAL in 1 CARTON (25021-115-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 150MG BASE/ML
Approval Date:Sep 30, 2011TE:APRLD:No

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