Details for New Drug Application (NDA): 215641
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NDA 215641 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 215641
| Tradename: | CLOTRIMAZOLE |
| Applicant: | Thinq Pharm-cro Pvt |
| Ingredient: | clotrimazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215641
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | clotrimazole | TROCHE/LOZENGE;ORAL | 215641 | ANDA | Rising Pharma Holdings, Inc. | 16571-686 | 16571-686-07 | 70 LOZENGE in 1 BOTTLE (16571-686-07) |
| CLOTRIMAZOLE | clotrimazole | TROCHE/LOZENGE;ORAL | 215641 | ANDA | Rising Pharma Holdings, Inc. | 16571-686 | 16571-686-14 | 140 LOZENGE in 1 BOTTLE (16571-686-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TROCHE/LOZENGE;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 29, 2024 | TE: | AB | RLD: | No | ||||
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