Details for New Drug Application (NDA): 214869
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NDA 214869 describes DHIVY, which is a drug marketed by Avion Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DHIVY profile page.
The generic ingredient in DHIVY 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.
The generic ingredient in DHIVY 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 214869
| Tradename: | DHIVY |
| Applicant: | Avion Pharms |
| Ingredient: | carbidopa; levodopa |
| Patents: | 3 |
Suppliers and Packaging for NDA: 214869
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DHIVY | carbidopa; levodopa | TABLET;ORAL | 214869 | NDA | Avion Pharmaceuticals, LLC | 75854-701 | 75854-701-01 | 100 TABLET in 1 BOTTLE (75854-701-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
| Approval Date: | Nov 12, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 28, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING PARKINSON'S DISEASE BY ORALLY ADMINISTERING A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 28, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING PARKINSON'S DISEASE BY ORALLY ADMINISTERING SEGMENTS OF A FUNCTIONALLY MULTISCORED, BILAYERED TABLET HAVING CARBIDOPA—25 MG/LEVODOPA—100 MG, EACH SEGMENT HAVING CARBIDOPA—6.25 MG/LEVODOPA—25 MG | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 28, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
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