Indomethacin Rectal Suppository

Brand(s): Indocin
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: G&W Laboratories, Inc. (2011-07-12)
Oldest Current Product: 1992-08-31
License(s): ANDA

RxNORM: RECTAL SUPPOSITORY\INDOMETHACIN
FDAOB: RECTAL\SUPPOSITORY\INDOMETHACIN
SPL Active: RECTAL\SUPPOSITORY\INDOMETHACIN
SPL Moiety: RECTAL\SUPPOSITORY\INDOMETHACIN

product(s) by strength(s)

indomethacin 50 mg rectal suppository

generic product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	007130176		ANDA	G&W Laboratories, Inc.	1992-08-31	INDOMETHACIN	RECTAL	SUPPOSITORY	ANDA073314	a8ed14ef-cd4b-3be7-0b5f-b677c72d2e88
2	422110102	Indocin	ANDA	Iroko Pharmaceuticals, Llc	1992-08-31	INDOMETHACIN	RECTAL	SUPPOSITORY	ANDA073314	e30a54dc-b62a-4ef7-9bea-daa8f5a685be

application(s)

#	id	title	deprecated	applicant	approved	approved drug
1	ANDA073314	INDOMETHACIN		G AND W LABORATORIES INC	1992-08-31	ANDA073314_001
2	NDA017814	INDOCIN	True	IROKO PHARMACEUTICALS LLC	1984-08-13	NDA017814_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	ANDA073314_001	RX	INDOMETHACIN (50MG)	RECTAL	SUPPOSITORY	True	1992-08-31	INDOMETHACIN
2	NDA017814_001	discontinued	INDOMETHACIN (50MG)	RECTAL	SUPPOSITORY	False	1984-08-13	INDOCIN

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	a8ed14ef-cd4b-3be7-0b5f-b677c72d2e88 (view SPL)		prescription	Human Prescription	G&W Laboratories, Inc.	MANUFACTURE	2011-07-12	1	007130176
2	e30a54dc-b62a-4ef7-9bea-daa8f5a685be (view SPL)		prescription	Human Prescription	Iroko Pharmaceuticals, Llc	MANUFACTURE	2011-07-12	2	422110102

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