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Last Updated: May 28, 2024

Details for New Drug Application (NDA): 020743

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NDA 020743 describes NORITATE, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the NORITATE profile page.

The generic ingredient in NORITATE is metronidazole. There are eighteen drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020743
Formulation / Manufacturing:see details
Pharmacology for NDA: 020743
Medical Subject Heading (MeSH) Categories for 020743
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:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 26, 1997TE:RLD:Yes

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