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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743012DuopaNDAAbbvie Inc.2015-01-15CARBIDOPA, LEVODOPAENTERALSUSPENSIONNDA2039527066d371-dc6a-0d6f-7bed-e5dd4ee912da

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA203952DUOPAABBVIE INC2015-01-09ORPHAN DRUG EXCLUSIVITY [2022-01-09]
NEW PRODUCT [2018-01-09]
NDA203952_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203952_001RXLEVODOPA (20MG/ML), CARBIDOPA (4.63MG/ML)ENTERALSUSPENSIONTrue2015-01-09DUOPA

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
17066d371-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: 1975prescriptionHuman PrescriptionAbbvie Inc.2015-05-27119000743012

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