Details for New Drug Application (NDA): 076387
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The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Fifteen 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 |
Formulation / Manufacturing: | see details |
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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