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US Department of Justice

Generated: April 22, 2019

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Details for New Drug Application (NDA): 078084

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NDA 078084 describes METRONIDAZOLE IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare Corp, Hospira, Inforlife, and Mylan Labs Ltd, and is included in four NDAs. It is available from four suppliers. Additional details are available on the METRONIDAZOLE IN PLASTIC CONTAINER profile page.

The generic ingredient in METRONIDAZOLE IN PLASTIC CONTAINER is metronidazole. There are eighteen drug master file entries for this compound. Ninety-one suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Summary for 078084
Applicant:Baxter Hlthcare Corp
Formulation / Manufacturing:see details
Pharmacology for NDA: 078084
Medical Subject Heading (MeSH) Categories for 078084
Suppliers and Packaging for NDA: 078084
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 078084 ANDA West-ward Pharmaceutical Corp 0143-9772 0143-9772-26 100 mL in 1 BAG (0143-9772-26)
METRONIDAZOLE IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 078084 ANDA Baxter Healthcare Corporation 36000-001 36000-001-24 24 BAG in 1 CARTON (36000-001-24) > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/100ML
Approval Date:Mar 31, 2008TE:APRLD:No

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