Carbidopa / Levodopa Extended Release Oral Capsule

Brand(s)
Rytary
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Impax Laboratories, Inc. (2015-01-23)
Oldest Current Product
2015-01-12
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\CARBIDOPA:LEVODOPA
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\CARBIDOPA: LEVODOPA
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\CARBIDOPA: LEVODOPA
ORAL\CAPSULE\CARBIDOPA: LEVODOPA
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\CARBIDOPA ANHYDROUS: LEVODOPA
ORAL\CAPSULE\CARBIDOPA ANHYDROUS: LEVODOPA

product(s) by strength(s)

8 hr carbidopa 23.75 mg / levodopa 95 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648960661RytaryNDAImpax Laboratories, Inc.2015-01-12CARBIDOPA, LEVODOPAORALCAPSULE, EXTENDED RELEASENDA2033126c1f7cd4-de56-45c1-a734-5e77b4aeb6f7

8 hr carbidopa 36.25 mg / levodopa 145 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648960662RytaryNDAImpax Laboratories, Inc.2015-01-12CARBIDOPA, LEVODOPAORALCAPSULENDA2033126c1f7cd4-de56-45c1-a734-5e77b4aeb6f7

8 hr carbidopa 48.75 mg / levodopa 195 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648960663RytaryNDAImpax Laboratories, Inc.2015-01-12CARBIDOPA, LEVODOPAORALCAPSULENDA2033126c1f7cd4-de56-45c1-a734-5e77b4aeb6f7

8 hr carbidopa 61.25 mg / levodopa 245 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1648960664RytaryNDAImpax Laboratories, Inc.2015-01-12CARBIDOPA, LEVODOPAORALCAPSULENDA2033126c1f7cd4-de56-45c1-a734-5e77b4aeb6f7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203312RYTARYIMPAX LABORATORIES INC2015-01-07p7094427, TREATMENT OF PARKINSON'S DISEASE, SUBSTANCE
p8557283, TREATMENT OF PARKINSON'S DISEASE/ TREATMENT OF PARKINSON'S DISEASE, SUBSTANCE
p9089608, SUBSTANCE
p8454998, TREATMENT OF PARKINSON'S DISEASE/ TREATMENT OF PARKINSON'S DISEASE/ TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION/ TREATMENT OF POST-ENCEPHALITIC PARKINSONISM/ TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, SUBSTANCE
p8377474, TREATMENT OF PARKINSON'S DISEASE/ TREATMENT OF PARKINSON'S DISEASE, SUBSTANCE
p9089607, TREATMENT OF PARKINSON'S DISEASE/ METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA, SUBSTANCE
NEW DOSAGE FORM [2018-01-07]NDA203312_001, NDA203312_002, NDA203312_003, NDA203312_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203312_001RXCARBIDOPA (23.75MG), LEVODOPA (95MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-01-07RYTARY
2NDA203312_002RXLEVODOPA (145MG), CARBIDOPA (36.25MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-01-07RYTARY
3NDA203312_003RXCARBIDOPA (48.75MG), LEVODOPA (195MG)ORALCAPSULE, EXTENDED RELEASEFalse2015-01-07RYTARY
4NDA203312_004RXLEVODOPA (245MG), CARBIDOPA (61.25MG)ORALCAPSULE, EXTENDED RELEASETrue2015-01-07RYTARY

patent(s)

#idexpiration dateapplication(s)
1p7094427 (view patent)2022-05-29NDA203312
2p8377474 (view patent)2028-12-26NDA203312
3p8454998 (view patent)2028-12-26NDA203312
4p8557283 (view patent)2028-12-26NDA203312
5p9089607 (view patent)2028-12-26NDA203312
6p9089608 (view patent)2028-12-26NDA203312

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16c1f7cd4-de56-45c1-a734-5e77b4aeb6f7 (view SPL)These highlights do not include all the information needed to use RYTARY safely and effectively. See full prescribing information for RYTARY. RYTARY (carbidopa and levodopa) extended-release capsules, for oral useInitial U.S. Approval: 1975prescriptionHuman PrescriptionImpax Laboratories, Inc.2015-01-232648960661, 648960662, 648960663, 648960664

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