Details for New Drug Application (NDA): 212281
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NDA 212281 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. 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 212281
| Tradename: | CLOTRIMAZOLE |
| Applicant: | Trupharma |
| Ingredient: | clotrimazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212281
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | clotrimazole | SOLUTION;TOPICAL | 212281 | ANDA | TruPharma LLC | 52817-800 | 52817-800-30 | 1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE |
| CLOTRIMAZOLE | clotrimazole | SOLUTION;TOPICAL | 212281 | ANDA | Bryant Ranch Prepack | 72162-2178 | 72162-2178-3 | 1 BOTTLE in 1 CARTON (72162-2178-3) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1% | ||||
| Approval Date: | Jul 25, 2019 | TE: | AT | RLD: | No | ||||
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