Carbidopa / Levodopa Oral Suspension

Brand(s): Duopa
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Abbvie Inc. (2015-05-27)
Oldest Current Product: 2015-01-15
License(s): NDA

RxNORM: ORAL SUSPENSION\CARBIDOPA:LEVODOPA
FDAOB: ENTERAL\SUSPENSION\CARBIDOPA: LEVODOPA
SPL Active: ENTERAL\SUSPENSION\CARBIDOPA: LEVODOPA
SPL Moiety: ENTERAL\SUSPENSION\CARBIDOPA ANHYDROUS: LEVODOPA

product(s) by strength(s)

carbidopa 4.63 mg/ml / levodopa 20 mg/ml oral suspension

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000743012	Duopa	NDA	Abbvie Inc.	2015-01-15	CARBIDOPA, LEVODOPA	ENTERAL	SUSPENSION	NDA203952	7066d371-dc6a-0d6f-7bed-e5dd4ee912da

application(s)

#	id	title	applicant	approved	exclusivity	approved drug
1	NDA203952	DUOPA	ABBVIE INC	2015-01-09	ORPHAN DRUG EXCLUSIVITY [2022-01-09] NEW PRODUCT [2018-01-09]	NDA203952_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA203952_001	RX	LEVODOPA (20MG/ML), CARBIDOPA (4.63MG/ML)	ENTERAL	SUSPENSION	True	2015-01-09	DUOPA

spl(s)

#	id	title	category	type	labeler	last update	version	product(s)
1	7066d371-dc6a-0d6f-7bed-e5dd4ee912da (view SPL)	These highlights do not include all the information needed to use DUOPA safely and effectively. See full prescribing information for DUOPA. DUOPA (carbidopa and levodopa) enteral suspension Initial U.S. Approval: 1975	prescription	Human Prescription	Abbvie Inc.	2015-05-27	119	000743012

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