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Boehringer Ingelheim

Last Updated: December 3, 2023

Details for New Drug Application (NDA): 020334

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NDA 020334 describes FLAGYL, which is a drug marketed by 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 020334
Formulation / Manufacturing:see details
Pharmacology for NDA: 020334
Medical Subject Heading (MeSH) Categories for 020334
Suppliers and Packaging for NDA: 020334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLAGYL metronidazole CAPSULE;ORAL 020334 NDA Pfizer Laboratories Div Pfizer Inc 0025-1942 0025-1942-34 100 BLISTER PACK in 1 CARTON (0025-1942-34) / 1 CAPSULE in 1 BLISTER PACK
FLAGYL metronidazole CAPSULE;ORAL 020334 NDA Pfizer Laboratories Div Pfizer Inc 0025-1942 0025-1942-50 50 CAPSULE in 1 BOTTLE (0025-1942-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength375MG
Approval Date:May 3, 1995TE:ABRLD:Yes

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