Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050558
Company: PAI HOLDINGS PHARM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINACEF	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	Yes	No
ZINACEF	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ZINACEF	CEFUROXIME SODIUM	EQ 7.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2021	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050558s076lbl.pdf
02/11/2020	SUPPL-75	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050558s075lbl.pdf
09/25/2014	SUPPL-69	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf
07/30/2007	SUPPL-67	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf
05/19/2004	SUPPL-57	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf
10/12/2001	SUPPL-50	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf