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Last Updated: November 2, 2024

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 Bausch and is included in three NDAs. It is available from three suppliers. 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. Seventy-two suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 019737
Tradename:METROGEL
Applicant:Galderma Labs Lp
Ingredient:metronidazole
Patents:0
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 66993-962-45 1 TUBE in 1 CARTON (66993-962-45) / 45 g in 1 TUBE

Profile for product number 001

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

Expired US Patents for NDA 019737

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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