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Generated: April 27, 2017

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Details for New Drug Application (NDA): 050558

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NDA 050558 describes ZINACEF, which is a drug marketed by Igi Labs Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the ZINACEF profile page.

The generic ingredient in ZINACEF is cefuroxime sodium. There are sixty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

Summary for NDA: 050558

Formulation / Manufacturing:see details

Pharmacology for NDA: 050558


Suppliers and Packaging for NDA: 050558

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefuroxime sodium
INJECTABLE;INJECTION 050558 NDA Covis Pharmaceuticals Inc 24987-352 24987-352-10 10 VIAL in 1 TRAY (24987-352-10) > 8.3 mL in 1 VIAL
cefuroxime sodium
INJECTABLE;INJECTION 050558 NDA Covis Pharmaceuticals Inc 24987-354 24987-354-10 10 VIAL in 1 TRAY (24987-354-10) > 16 mL in 1 VIAL

Summary for product number 002

Approval Date:Oct 19, 1983TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5GM BASE/VIAL
Approval Date:Oct 19, 1983TE:APRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 7.5GM BASE/VIAL
Approval Date:Oct 23, 1986TE:APRLD:Yes

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