Details for New Drug Application (NDA): 064159
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NDA 064159 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.
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 064159
| Tradename: | CLINDAMYCIN PHOSPHATE |
| Applicant: | Fougera Pharms Inc |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 064159
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 064159
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | clindamycin phosphate | SOLUTION;TOPICAL | 064159 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0201 | 0168-0201-30 | 1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLE |
| CLINDAMYCIN PHOSPHATE | clindamycin phosphate | SOLUTION;TOPICAL | 064159 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0201 | 0168-0201-60 | 1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | EQ 1% BASE | ||||
| Approval Date: | Jun 5, 1997 | TE: | AT | RLD: | No | ||||
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