Details for New Drug Application (NDA): 079067
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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 079067
Tradename: | METRONIDAZOLE |
Applicant: | Alembic Pharms Ltd |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 079067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | TABLET;ORAL | 079067 | ANDA | Alembic Pharmaceuticals Limited | 46708-428 | 46708-428-30 | 30 TABLET in 1 BOTTLE (46708-428-30) |
METRONIDAZOLE | metronidazole | TABLET;ORAL | 079067 | ANDA | Alembic Pharmaceuticals Limited | 46708-428 | 46708-428-31 | 100 TABLET in 1 BOTTLE (46708-428-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Mar 13, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 13, 2009 | TE: | AB | RLD: | No |
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