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Details for New Drug Application (NDA): 012623

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NDA 012623 describes FLAGYL, which is a drug marketed by Gd Searle Llc, Pfizer, and Baxter Hlthcare, and is included in five NDAs. It is available from one supplier. Additional details are available on the FLAGYL profile page.

The generic ingredient in FLAGYL is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.

Summary for NDA: 012623

Tradename:
FLAGYL
Applicant:
Gd Searle Llc
Ingredient:
metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 012623

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 012623

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLAGYL
metronidazole
TABLET;ORAL 012623 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1821 0025-1821-31 100 TABLET, FILM COATED in 1 BOTTLE (0025-1821-31)
FLAGYL
metronidazole
TABLET;ORAL 012623 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1821 0025-1821-50 50 TABLET, FILM COATED in 1 BOTTLE (0025-1821-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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