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Generated: November 20, 2017

DrugPatentWatch Database Preview

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 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. Eighty-four suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for 020743

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 020743

Ingredient-typeNitroimidazoles

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 Valeant Pharmaceuticals North America LLC 0187-5202 0187-5202-35 3.5 g in 1 TUBE (0187-5202-35)
NORITATE
metronidazole
CREAM;TOPICAL 020743 NDA Valeant Pharmaceuticals North America LLC 0187-5202 0187-5202-60 60 g in 1 TUBE (0187-5202-60)

Summary for product number 001

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


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