Details for New Drug Application (NDA): 204417
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NDA 204417 describes ELEPSIA XR, which is a drug marketed by Tripoint and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the ELEPSIA XR profile page.
The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 204417
| Tradename: | ELEPSIA XR |
| Applicant: | Tripoint |
| Ingredient: | levetiracetam |
| Patents: | 5 |
Pharmacology for NDA: 204417
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 204417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417 | NDA | Sun Pharma Advanced Research Company Limited | 47133-574 | 47133-574-13 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-13) |
| ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417 | NDA | Sun Pharma Advanced Research Company Limited | 47133-574 | 47133-574-83 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-83) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM | ||||
| Approval Date: | Dec 20, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 8,163,306 | Patent Expiration: | Sep 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,425,938 | Patent Expiration: | Feb 22, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,431,156 | Patent Expiration: | Oct 31, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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