Cefotetan Injectable Solution

Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: App Pharmaceuticals, Llc (2015-08-28)
Oldest Current Product: 2009-11-18
License(s): ANDA

RxNORM: INJECTABLE SOLUTION\CEFOTETAN
FDAOB: INJECTION\INJECTION\CEFOTETAN DISODIUM\rdfq
SPL Active: INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN DISODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN DISODIUM
INTRAVENOUS\INJECTION, SOLUTION\CEFOTETAN DISODIUM
SPL Moiety: INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFOTETAN
INTRAVENOUS\INJECTION, SOLUTION\CEFOTETAN

product(s) by strength(s)

cefotetan 20 mg/ml injectable solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	002643173	ANDA	B. Braun Medical Inc.	2010-08-20	CEFOTETAN DISODIUM	INTRAVENOUS	INJECTION, SOLUTION	ANDA065430	bc4d6887-e543-416e-9865-c0af4060af9c

cefotetan 200 mg/ml injectable solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	633230396	ANDA	App Pharmaceuticals, Llc	2009-12-03	CEFOTETAN DISODIUM	INTRAVENOUS	INJECTION, POWDER, FOR SOLUTION	ANDA065375	c6b8667e-8bb6-ea58-a969-2f74458bc611

cefotetan 40 mg/ml injectable solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	002643175	ANDA	B. Braun Medical Inc.	2010-08-20	CEFOTETAN DISODIUM	INTRAVENOUS	INJECTION, SOLUTION	ANDA065430	bc4d6887-e543-416e-9865-c0af4060af9c

cefotetan 400 mg/ml injectable solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	633230385	ANDA	App Pharmaceuticals, Llc	2009-11-18	CEFOTETAN DISODIUM	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA065374	bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e

cefotetan 500 mg/ml injectable solution

generic product(s)(s)

#	id	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	633230386	ANDA	App Pharmaceuticals, Llc	2009-11-18	CEFOTETAN DISODIUM	INTRAMUSCULAR	INJECTION, POWDER, FOR SOLUTION	ANDA065374	bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e

application(s)

#	id	title	deprecated	applicant	approved	approved drug
1	ANDA063293	CEFOTAN	True	IGI LABORATORIES INC	1993-04-29	ANDA063293_001, ANDA063293_002
2	ANDA065374	CEFOTETAN		FRESENIUS KABI USA LLC	2007-08-09	ANDA065374_001, ANDA065374_002
3	ANDA065375	CEFOTETAN		FRESENIUS KABI USA LLC	2007-08-09	ANDA065375_001
4	ANDA065430	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER		B BRAUN MEDICAL INC	2007-08-09	ANDA065430_001, ANDA065430_002
5	ANDA091030	CEFOTETAN		WEST-WARD PHARMACEUTICAL CORP	2011-10-26	ANDA091030_001
6	ANDA091031	CEFOTETAN		WEST-WARD PHARMACEUTICAL CORP	2011-10-26	ANDA091031_001, ANDA091031_002
7	NDA050588	CEFOTAN	True	IGI LABORATORIES INC	1985-12-27	NDA050588_001, NDA050588_002, NDA050588_003
8	NDA050694	CEFOTAN IN PLASTIC CONTAINER	True	IGI LABORATORIES INC	1993-07-30	NDA050694_001, NDA050694_002

application drug(s)

#	id	category/deprecated	ingredient strength(s)	dose form	rld	TE	approved	application
1	ANDA063293_001	discontinued	CEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)	INJECTION	False		1993-04-29	CEFOTAN
2	ANDA063293_002	discontinued	CEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)	INJECTION	False		1993-04-29	CEFOTAN
3	ANDA065374_001	RX	CEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)	INJECTION	True	AP	2007-08-09	CEFOTETAN
4	ANDA065374_002	RX	CEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)	INJECTION	True	AP	2007-08-09	CEFOTETAN
5	ANDA065375_001	RX	CEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)	INJECTION	True	AP	2007-08-09	CEFOTETAN
6	ANDA065430_001	RX	CEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)	INJECTION	True		2007-08-09	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
7	ANDA065430_002	RX	CEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)	INJECTION	True		2007-08-09	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
8	ANDA091030_001	RX	CEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)	INJECTION	False	AP	2011-10-26	CEFOTETAN
9	ANDA091031_001	RX	CEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)	INJECTION	False	AP	2011-10-26	CEFOTETAN
10	ANDA091031_002	RX	CEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)	INJECTION	False	AP	2011-10-26	CEFOTETAN
11	NDA050588_001	discontinued	CEFOTETAN DISODIUM (EQ 1GM BASE/VIAL)	INJECTION	False		1985-12-27	CEFOTAN
12	NDA050588_002	discontinued	CEFOTETAN DISODIUM (EQ 2GM BASE/VIAL)	INJECTION	False		1985-12-27	CEFOTAN
13	NDA050588_003	discontinued	CEFOTETAN DISODIUM (EQ 10GM BASE/VIAL)	INJECTION	False		1988-04-25	CEFOTAN
14	NDA050694_001	discontinued	CEFOTETAN DISODIUM (EQ 40MG BASE/ML)	INJECTION	False		1993-07-30	CEFOTAN IN PLASTIC CONTAINER
15	NDA050694_002	discontinued	CEFOTETAN DISODIUM (EQ 20MG BASE/ML)	INJECTION	False		1993-07-30	CEFOTAN IN PLASTIC CONTAINER

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	bc4d6887-e543-416e-9865-c0af4060af9c (view SPL)	CEFOTETAN FOR INJECTION USP AND DEXTROSE INJECTION USP	prescription	Human Prescription	B. Braun Medical Inc.		2013-02-14	6	002643173, 002643175
2	bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e (view SPL)	Cefotetan for Injection, USP	prescription	Human Prescription	App Pharmaceuticals, Llc	API MANUFACTURE, MANUFACTURE	2015-05-20	4	633230385, 633230386
3	c6b8667e-8bb6-ea58-a969-2f74458bc611 (view SPL)	Cefotetan for Injection, USP	prescription	Human Prescription	App Pharmaceuticals, Llc	API MANUFACTURE, MANUFACTURE	2015-08-28	4	633230396

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII