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Details for New Drug Application (NDA): 020334

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NDA 020334 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: 020334

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 020334


Suppliers and Packaging for NDA: 020334

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 020334 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1942 0025-1942-34 100 BLISTER PACK in 1 CARTON (0025-1942-34) > 1 CAPSULE in 1 BLISTER PACK
CAPSULE;ORAL 020334 NDA G.D. Searle LLC Division of Pfizer Inc 0025-1942 0025-1942-50 50 CAPSULE in 1 BOTTLE (0025-1942-50)

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.