Details for New Drug Application (NDA): 216185
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NDA 216185 describes MOTPOLY XR, which is a drug marketed by Aucta 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 MOTPOLY XR profile page.
The generic ingredient in MOTPOLY XR is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
The generic ingredient in MOTPOLY XR is lacosamide. There are twenty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 216185
| Tradename: | MOTPOLY XR |
| Applicant: | Aucta |
| Ingredient: | lacosamide |
| Patents: | 3 |
Pharmacology for NDA: 216185
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 216185
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOTPOLY XR | lacosamide | CAPSULE, EXTENDED RELEASE;ORAL | 216185 | NDA | Aucta Pharmaceuticals, Inc. | 73289-0063 | 73289-0063-1 | 1 BLISTER PACK in 1 CARTON (73289-0063-1) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
| MOTPOLY XR | lacosamide | CAPSULE, EXTENDED RELEASE;ORAL | 216185 | NDA | Aucta Pharmaceuticals, Inc. | 73289-0063 | 73289-0063-2 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0063-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 4, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 5, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 5, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 5, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG | ||||||||
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