Budesonide Rectal Foam

Brand(s): Uceris
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Salix Pharmaceuticals, Inc. (2014-10-20)
Oldest Current Product: 2014-12-01
License(s): NDA

RxNORM: RECTAL FOAM\BUDESONIDE
FDAOB: RECTAL\AEROSOL, FOAM\BUDESONIDE
SPL Active: RECTAL\AEROSOL, FOAM\BUDESONIDE
SPL Moiety: RECTAL\AEROSOL, FOAM\BUDESONIDE

product(s) by strength(s)

14 actuat budesonide 2 mg/actuat rectal foam

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	656490651	Uceris	NDA	Salix Pharmaceuticals, Inc.	2014-12-01	BUDESONIDE	RECTAL	AEROSOL, FOAM	NDA205613	230e4596-2a9b-4d55-b0a0-0cabbcff5289

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug
1	NDA205613	UCERIS	VALEANT PHARMACEUTICALS INTERNATIONAL	2014-10-07	p5914122, SUBSTANCE	NEW PRODUCT [2017-10-07]	NDA205613_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA205613_001	RX	BUDESONIDE (2MG/ACTUATION)	RECTAL	AEROSOL, FOAM	True	2014-10-07	UCERIS

patent(s)

#	id	expiration date	application(s)
1	p5914122 (view patent)	2015-12-19	NDA205613

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	230e4596-2a9b-4d55-b0a0-0cabbcff5289 (view SPL)	These highlights do not include all the information needed to use UCERIS rectal foam safely and effectively. See full prescribing information for UCERIS rectal foam. UCERIS (budesonide) rectal foam Initial U.S. Approval: 1997	prescription	Human Prescription	Salix Pharmaceuticals, Inc.	API MANUFACTURE	2014-10-20	10	656490651

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