Details for New Drug Application (NDA): 205245
✉ 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 205245
Tradename: | METRONIDAZOLE |
Applicant: | Heritage Pharms Inc |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205245
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | TABLET;ORAL | 205245 | ANDA | Major Pharmaceuticals | 0904-7126 | 0904-7126-61 | 100 BLISTER PACK in 1 CARTON (0904-7126-61) / 1 TABLET in 1 BLISTER PACK |
METRONIDAZOLE | metronidazole | TABLET;ORAL | 205245 | ANDA | Major Pharmaceuticals | 0904-7156 | 0904-7156-61 | 100 BLISTER PACK in 1 CARTON (0904-7156-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Sep 23, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Sep 23, 2015 | TE: | AB | RLD: | No |
Complete Access Available with Subscription