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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020531

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NDA 020531 describes METROCREAM, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the METROCREAM profile page.

The generic ingredient in METROCREAM is metronidazole. There are eighteen drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 020531
Tradename:METROCREAM
Applicant:Galderma Labs Lp
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020531
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 020531
Suppliers and Packaging for NDA: 020531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METROCREAM metronidazole CREAM;TOPICAL 020531 NDA Galderma Laboratories, L.P. 0299-3836 0299-3836-45 1 TUBE in 1 CARTON (0299-3836-45) > 45 g in 1 TUBE
METROCREAM metronidazole CREAM;TOPICAL 020531 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-960 66993-960-45 1 TUBE in 1 CARTON (66993-960-45) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.75%
Approval Date:Sep 20, 1995TE:ABRLD:Yes

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