Details for New Drug Application (NDA): 090222
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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 090222
Tradename: | METRONIDAZOLE |
Applicant: | Alembic |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090222
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | TABLET, EXTENDED RELEASE;ORAL | 090222 | ANDA | Alembic Pharmaceuticals Limited | 46708-021 | 46708-021-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30) |
METRONIDAZOLE | metronidazole | TABLET, EXTENDED RELEASE;ORAL | 090222 | ANDA | Alembic Pharmaceuticals Limited | 46708-021 | 46708-021-31 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | May 5, 2010 | TE: | RLD: | No |
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