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Generated: March 19, 2019

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Details for New Drug Application (NDA): 063002

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NDA 063002 describes ANCEF IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the ANCEF IN PLASTIC CONTAINER profile page.

The generic ingredient in ANCEF IN PLASTIC CONTAINER is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 063002
Applicant:Baxter Hlthcare
Ingredient:cefazolin sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 063002
Medical Subject Heading (MeSH) Categories for 063002
Suppliers and Packaging for NDA: 063002
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANCEF IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 063002 ANDA Baxter Healthcare Corporation 0338-3503 0338-3503-41 24 BAG in 1 CASE (0338-3503-41) > 50 mL in 1 BAG

Profile for product number 001

Approval Date:Mar 28, 1991TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/ML
Approval Date:Mar 28, 1991TE:RLD:No

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