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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

Igi Labs Inc
cefuroxime sodium

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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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.