Details for New Drug Application (NDA): 078338
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NDA 078338 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, P And L, Novitium Pharma, Sciegen Pharms Inc, Teva, Trupharma, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, and Glenmark Speclt, and is included in nineteen NDAs. It is available from twenty-four suppliers. Additional details are available on the CLOTRIMAZOLE profile page.
The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 078338
| Tradename: | CLOTRIMAZOLE |
| Applicant: | Fougera Pharms |
| Ingredient: | clotrimazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078338
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | clotrimazole | CREAM;TOPICAL | 078338 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0133 | 0168-0133-15 | 15 g in 1 TUBE (0168-0133-15) |
| CLOTRIMAZOLE | clotrimazole | CREAM;TOPICAL | 078338 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0133 | 0168-0133-30 | 30 g in 1 TUBE (0168-0133-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Sep 2, 2008 | TE: | AB | RLD: | No | ||||
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