Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050588
Company: PAI HOLDINGS PHARM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFOTAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	No
CEFOTAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	No
CEFOTAN	CEFOTETAN DISODIUM	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2017	SUPPL-32	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/2017/050588s032lbl.pdf
06/25/2004	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf
06/20/2003	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf
03/04/2003	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf