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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 050643

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050643

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050643s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050643Orig1s027ltr.pdf
04/29/2013	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/25/2014	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf
07/30/2007	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf
05/19/2004	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf
11/09/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
10/12/2001	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf
07/12/2001	SUPPL-10	Labeling		Label is not available on this site.
12/23/1996	SUPPL-9	Labeling		Label is not available on this site.
09/11/1996	SUPPL-8	Labeling		Label is not available on this site.
12/23/1996	SUPPL-7	Labeling		Label is not available on this site.
09/29/1995	SUPPL-6	Labeling		Label is not available on this site.
10/27/1994	SUPPL-5	Labeling		Label is not available on this site.
02/06/1995	SUPPL-4	Labeling		Label is not available on this site.
03/30/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-2	Labeling		Label is not available on this site.
01/15/1993	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

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

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