Details for New Drug Application (NDA): 078338
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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 078338
Tradename: | CLOTRIMAZOLE |
Applicant: | Fougera Pharms |
Ingredient: | clotrimazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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