Details for New Drug Application (NDA): 202810
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The generic ingredient in OXTELLAR XR is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-five 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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