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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019737

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NDA 019737 describes METROGEL, which is a drug marketed by Galderma Labs Lp and Medicis and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the METROGEL profile page.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 019737
Applicant:Galderma Labs Lp
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019737
Suppliers and Packaging for NDA: 019737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METROGEL metronidazole GEL;TOPICAL 019737 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-962 N 66993-962-45
METROGEL metronidazole GEL;TOPICAL 019737 NDA AUTHORIZED GENERIC Owen Laboratories 69007-835 N 69007-835-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.75%
Approval Date:Nov 22, 1988TE:ABRLD:Yes

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