Details for New Drug Application (NDA): 020743
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The generic ingredient in NORITATE is metronidazole. There are eighteen drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020743
Tradename: | NORITATE |
Applicant: | Bausch |
Ingredient: | metronidazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020743
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORITATE | metronidazole | CREAM;TOPICAL | 020743 | NDA | Bausch Health US, LLC | 0187-5202 | 0187-5202-60 | 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE |
NORITATE | metronidazole | CREAM;TOPICAL | 020743 | NDA | Oceanside Pharmaceuticals | 68682-202 | 68682-202-60 | 60 g in 1 TUBE (68682-202-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Sep 26, 1997 | TE: | RLD: | Yes |
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