Details for New Drug Application (NDA): 076408
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The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.
Summary for 076408
Tradename: | METRONIDAZOLE |
Applicant: | Fougera Pharms |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076408
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | CREAM;TOPICAL | 076408 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0323 | 0168-0323-46 | 45 g in 1 TUBE (0168-0323-46) |
METRONIDAZOLE | metronidazole | CREAM;TOPICAL | 076408 | ANDA | Bryant Ranch Prepack | 72162-2259 | 72162-2259-2 | 45 g in 1 TUBE (72162-2259-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.75% | ||||
Approval Date: | May 28, 2004 | TE: | AB | RLD: | No |
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