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Details for New Drug Application (NDA): 064050

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NDA 064050 describes CLINDAMYCIN PHOSPHATE, which is a drug marketed by Alvogen Inc, Watson Labs, Wockhardt, Loch, Eurohlth Intl Sarl, Bristol Myers Squibb, Sagent Pharms, Renaissance Pharma, Sagent Strides, G And W Labs Inc, Marsam Pharms Llc, Versapharm, Solopak, Igi Labs Inc, Vintage Pharms, Fougera Pharms, Teva Parenteral, Boca Pharma Llc, Fresenius Kabi Usa, Abraxis Pharm, Perrigo New York, Fougera, Bedford, Taro Pharm Inds, Perrigo Uk Finco, Actavis Labs Ut Inc, Perrigo Israel, Mylan Pharms Inc, Tolmar, Actavis Mid Atlantic, Akorn Inc, Sandoz Inc, Abbvie, and Baxter Hlthcare, and is included in fifty-two 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-two 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 NDA: 064050

Perrigo New York
clindamycin phosphate
Therapeutic Class:Antibacterials

Pharmacology for NDA: 064050

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 064050

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clindamycin phosphate
SOLUTION;TOPICAL 064050 ANDA Perrigo New York Inc 45802-562 45802-562-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01) > 30 mL in 1 BOTTLE, WITH APPLICATOR
clindamycin phosphate
SOLUTION;TOPICAL 064050 ANDA Perrigo New York Inc 45802-562 45802-562-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02) > 60 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrengthEQ 1% BASE
Approval Date:Nov 30, 1995TE:ATRLD:No

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