Details for New Drug Application (NDA): 203458
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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 203458
Tradename: | METRONIDAZOLE |
Applicant: | Unichem |
Ingredient: | metronidazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 203458
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | TABLET;ORAL | 203458 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-226 | 29300-226-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-01) |
METRONIDAZOLE | metronidazole | TABLET;ORAL | 203458 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-226 | 29300-226-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 22, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 22, 2014 | TE: | AB | RLD: | No |
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