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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 648960661 | Rytary | NDA | Impax Laboratories, Inc. | 2015-01-12 | CARBIDOPA, LEVODOPA | ORAL | CAPSULE, EXTENDED RELEASE | NDA203312 | 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7 |
8 hr carbidopa 36.25 mg / levodopa 145 mg extended release oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 648960662 | Rytary | NDA | Impax Laboratories, Inc. | 2015-01-12 | CARBIDOPA, LEVODOPA | ORAL | CAPSULE | NDA203312 | 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7 |
8 hr carbidopa 48.75 mg / levodopa 195 mg extended release oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 648960663 | Rytary | NDA | Impax Laboratories, Inc. | 2015-01-12 | CARBIDOPA, LEVODOPA | ORAL | CAPSULE | NDA203312 | 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7 |
8 hr carbidopa 61.25 mg / levodopa 245 mg extended release oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 648960664 | Rytary | NDA | Impax Laboratories, Inc. | 2015-01-12 | CARBIDOPA, LEVODOPA | ORAL | CAPSULE | NDA203312 | 6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA203312 | RYTARY | IMPAX LABORATORIES INC | 2015-01-07 | p7094427, 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)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA203312_001 | RX | CARBIDOPA (23.75MG), LEVODOPA (95MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | 2015-01-07 | RYTARY |
| 2 | NDA203312_002 | RX | LEVODOPA (145MG), CARBIDOPA (36.25MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | 2015-01-07 | RYTARY |
| 3 | NDA203312_003 | RX | CARBIDOPA (48.75MG), LEVODOPA (195MG) | ORAL | CAPSULE, EXTENDED RELEASE | False | 2015-01-07 | RYTARY |
| 4 | NDA203312_004 | RX | LEVODOPA (245MG), CARBIDOPA (61.25MG) | ORAL | CAPSULE, EXTENDED RELEASE | True | 2015-01-07 | RYTARY |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7094427 (view patent) | 2022-05-29 | NDA203312 |
| 2 | p8377474 (view patent) | 2028-12-26 | NDA203312 |
| 3 | p8454998 (view patent) | 2028-12-26 | NDA203312 |
| 4 | p8557283 (view patent) | 2028-12-26 | NDA203312 |
| 5 | p9089607 (view patent) | 2028-12-26 | NDA203312 |
| 6 | p9089608 (view patent) | 2028-12-26 | NDA203312 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 6c1f7cd4-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: 1975 | prescription | Human Prescription | Impax Laboratories, Inc. | 2015-01-23 | 2 | 648960661, 648960662, 648960663, 648960664 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII