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. Seventy 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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