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Details for New Drug Application (NDA): 020901

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NDA 020901 describes METROLOTION, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the METROLOTION profile page.

The generic ingredient in METROLOTION is metronidazole. There are eighteen drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for NDA: 020901

Tradename:
METROLOTION
Applicant:
Galderma Labs Lp
Ingredient:
metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 020901

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 020901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METROLOTION
metronidazole
LOTION;TOPICAL 020901 NDA Galderma Laboratories, L.P. 0299-3838 0299-3838-02 1 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) > 59 mL in 1 BOTTLE, PLASTIC
METROLOTION
metronidazole
LOTION;TOPICAL 020901 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-961 66993-961-59 1 BOTTLE in 1 CARTON (66993-961-59) > 59.7 g in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.75%
Approval Date:Nov 24, 1998TE:ABRLD:Yes


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