Details for New Drug Application (NDA): 203312
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The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 203312
Tradename: | RYTARY |
Applicant: | Impax |
Ingredient: | carbidopa; levodopa |
Patents: | 8 |
Suppliers and Packaging for NDA: 203312
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312 | NDA | Amneal Pharmaceuticals LLC | 64896-661 | 64896-661-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01) |
RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312 | NDA | Amneal Pharmaceuticals LLC | 64896-661 | 64896-661-09 | 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 23.75MG;95MG | ||||
Approval Date: | Jan 7, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF PARKINSON'S DISEASE |
Expired US Patents for NDA 203312
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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