Details for New Drug Application (NDA): 204417
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The generic ingredient in ELEPSIA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-four 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 | TRIPOINT THERAPEUTICS, LLC | 80705-100 | 80705-100-02 | 1 BLISTER PACK in 1 CARTON (80705-100-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| ELEPSIA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417 | NDA | TRIPOINT THERAPEUTICS, LLC | 80705-100 | 80705-100-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-100-30) |
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: | ⤷ Get Started Free | Patent Expiration: | Sep 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 22, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 31, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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