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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 050588

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	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050588

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050588Orig1s000rev.pdf

Supplements

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) 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/2017/050588s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050588Orig1s032ltr.pdf
12/09/2015	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
06/25/2004	SUPPL-30	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50588slr030ltr.pdf
06/20/2003	SUPPL-29	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf
03/04/2003	SUPPL-27	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr027ltr.pdf
08/05/1999	SUPPL-26	Labeling		Label is not available on this site.
10/20/1995	SUPPL-25	Labeling		Label is not available on this site.
09/15/1994	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
07/30/1993	SUPPL-22	Labeling		Label is not available on this site.
09/12/1995	SUPPL-21	Labeling		Label is not available on this site.
07/30/1993	SUPPL-20	Labeling		Label is not available on this site.
09/29/1992	SUPPL-19	Labeling		Label is not available on this site.
05/18/1992	SUPPL-18	Labeling		Label is not available on this site.
11/25/1991	SUPPL-16	Labeling		Label is not available on this site.
11/25/1991	SUPPL-14	Labeling		Label is not available on this site.
11/25/1991	SUPPL-4	Labeling		Label is not available on this site.
11/25/1991	SUPPL-2	Efficacy-New Dosing Regimen		Label is not available on this site.

Labels for NDA 050588

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

Therapeutic Equivalents for NDA 050588

CEFOTAN

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFOTAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050588	PAI HOLDINGS PHARM
CEFOTETAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065374	FRESENIUS KABI USA

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFOTAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050588	PAI HOLDINGS PHARM
CEFOTETAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065374	FRESENIUS KABI USA

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