Details for New Drug Application (NDA): 079065
✉ Email this page to a colleague
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 079065
Tradename: | METRONIDAZOLE |
Applicant: | Alembic |
Ingredient: | metronidazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 079065
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | CAPSULE;ORAL | 079065 | ANDA | Alembic Pharmaceuticals Limited | 46708-435 | 46708-435-30 | 30 CAPSULE in 1 BOTTLE (46708-435-30) |
METRONIDAZOLE | metronidazole | CAPSULE;ORAL | 079065 | ANDA | Alembic Pharmaceuticals Limited | 46708-435 | 46708-435-31 | 100 CAPSULE in 1 BOTTLE (46708-435-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 375MG | ||||
Approval Date: | Jun 23, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription