Details for New Drug Application (NDA): 217186
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The generic ingredient in CREXONT is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-seven 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: | 29 |
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: | ⤷ Get Started Free | Patent Expiration: | Oct 7, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 7, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARKINSON'S DISEASE | ||||||||
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