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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 020743

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NDA 020743 describes NORITATE, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from one supplier. 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. Fifty-nine suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020743
Applicant:Valeant Pharms North
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 0187-5202-35 3.5 g in 1 TUBE (0187-5202-35)
NORITATE metronidazole CREAM;TOPICAL 020743 NDA Bausch Health US, LLC 0187-5202 0187-5202-60 60 g in 1 TUBE (0187-5202-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 26, 1997TE:RLD:Yes

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