Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065374
Company: FRESENIUS KABI USA

Products on ANDA 065374

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFOTETAN	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
CEFOTETAN	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065374

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065374ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/24/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/27/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065374

CEFOTETAN

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