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Generated: November 13, 2018

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Details for New Drug Application (NDA): 018657

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NDA 018657 describes FLAGYL I.V. RTU IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Pfizer and is included in two NDAs. It is available from one supplier. Additional details are available on the FLAGYL I.V. RTU IN PLASTIC CONTAINER profile page.

The generic ingredient in FLAGYL I.V. RTU IN PLASTIC CONTAINER 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 018657
Tradename:FLAGYL I.V. RTU IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018657
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 018657
Suppliers and Packaging for NDA: 018657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLAGYL I.V. RTU IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 018657 NDA Baxter Healthcare Corporation 0338-1055 0338-1055-48 24 BAG in 1 CARTON (0338-1055-48) > 100 mL in 1 BAG
FLAGYL I.V. RTU IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 018657 NDA Baxter Healthcare Corporation 0338-9541 0338-9541-24 24 BAG in 1 CARTON (0338-9541-24) > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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