Details for New Drug Application (NDA): 076522
✉ 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 076522
Tradename: | METRONIDAZOLE |
Applicant: | Chartwell Rx |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076522
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | metronidazole | CAPSULE;ORAL | 076522 | ANDA | Chartwell RX, LLC | 62135-836 | 62135-836-50 | 50 CAPSULE in 1 BOTTLE (62135-836-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 375MG | ||||
Approval Date: | Jan 29, 2004 | TE: | AB | RLD: | No |
Complete Access Available with Subscription