Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050643
Company: PAI HOLDINGS PHARM

Products on NDA 50643

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINACEF IN PLASTIC CONTAINER	CEFUROXIME SODIUM	EQ 15MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
ZINACEF IN PLASTIC CONTAINER	CEFUROXIME SODIUM	EQ 30MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 050643

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2021	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050643s027lbl.pdf
09/25/2014	SUPPL-22	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-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf
05/19/2004	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf
10/12/2001	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf