Details for New Drug Application (NDA): 212646
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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 212646
Tradename: | METRONIDAZOLE |
Applicant: | Alembic |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212646
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | GEL;TOPICAL | 212646 | ANDA | Alembic Pharmaceuticals Inc. | 62332-630 | 62332-630-45 | 1 TUBE in 1 CARTON (62332-630-45) / 45 g in 1 TUBE |
METRONIDAZOLE | metronidazole | GEL;TOPICAL | 212646 | ANDA | Alembic Pharmaceuticals Inc. | 62332-630 | 62332-630-55 | 1 BOTTLE, PUMP in 1 CARTON (62332-630-55) / 55 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | Sep 3, 2021 | TE: | AB | RLD: | No |
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