Details for New Drug Application (NDA): 217186
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NDA 217186 describes CREXONT, which is a drug marketed by Impax and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the CREXONT profile page.
The generic ingredient in CREXONT 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 CREXONT 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 217186
| Tradename: | CREXONT |
| Applicant: | Impax |
| Ingredient: | carbidopa; levodopa |
| Patents: | 10 |
Suppliers and Packaging for NDA: 217186
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186 | NDA | Amneal Pharmaceuticals LLC | 64896-967 | 64896-967-16 | 1 BOTTLE in 1 CARTON (64896-967-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
| CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186 | NDA | Amneal Pharmaceuticals LLC | 64896-967 | 64896-967-23 | 1 BOTTLE in 1 CARTON (64896-967-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 35MG;140MG | ||||
| Approval Date: | Aug 7, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 7, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 7, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 7, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
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