Details for New Drug Application (NDA): 217659
✉ Email this page to a colleague
The generic ingredient in OXCARBAZEPINE 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 217659
Tradename: | OXCARBAZEPINE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | oxcarbazepine |
Patents: | 0 |
Pharmacology for NDA: 217659
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 217659
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 217659 | ANDA | Ajanta Pharma USA Inc. | 27241-237 | 27241-237-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-237-01) |
OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 217659 | ANDA | Ajanta Pharma USA Inc. | 27241-238 | 27241-238-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-238-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
Approval Date: | Feb 22, 2024 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Feb 22, 2024 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Feb 22, 2024 | TE: | RLD: | No |
Complete Access Available with Subscription