Details for New Drug Application (NDA): 076387
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NDA 076387 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, P And L, Novitium Pharma, Sciegen Pharms, Teva, Tp Anda Holdings, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, Glenmark Speclt, and Taro, 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 076387
| Tradename: | CLOTRIMAZOLE |
| Applicant: | Hikma |
| Ingredient: | clotrimazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | clotrimazole | TROCHE/LOZENGE;ORAL | 076387 | ANDA | Hikma Pharmacuticals USA USA Inc. | 0054-4146 | 0054-4146-22 | 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22) |
| CLOTRIMAZOLE | clotrimazole | TROCHE/LOZENGE;ORAL | 076387 | ANDA | Hikma Pharmacuticals USA USA Inc. | 0054-4146 | 0054-4146-23 | 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TROCHE/LOZENGE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 29, 2004 | TE: | AB | RLD: | No | ||||
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