Details for New Drug Application (NDA): 202810
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NDA 202810 describes OXTELLAR XR, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OXTELLAR XR profile page.
The generic ingredient in OXTELLAR XR is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
The generic ingredient in OXTELLAR XR is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 202810
| Tradename: | OXTELLAR XR |
| Applicant: | Supernus Pharms |
| Ingredient: | oxcarbazepine |
| Patents: | 11 |
Pharmacology for NDA: 202810
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 202810
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXTELLAR XR | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810 | NDA | Supernus Pharmaceuticals, Inc. | 17772-121 | 17772-121-01 | 100 TABLET in 1 BOTTLE (17772-121-01) |
| OXTELLAR XR | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810 | NDA | Supernus Pharmaceuticals, Inc. | 17772-121 | 17772-121-07 | 7 TABLET in 1 BOTTLE (17772-121-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Oct 19, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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