Details for New Drug Application (NDA): 215796
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NDA 215796 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Macleods Pharms Ltd, Pai Holdings, Rubicon Research, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-eight NDAs. It is available from thirty-nine suppliers. Additional details are available on the OXCARBAZEPINE profile page.
The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 215796
| Tradename: | OXCARBAZEPINE |
| Applicant: | Riconpharma Llc |
| Ingredient: | oxcarbazepine |
| Patents: | 0 |
Pharmacology for NDA: 215796
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 215796
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 215796 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-611 | 50742-611-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-611-01) |
| OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 215796 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-612 | 50742-612-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-612-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Nov 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Nov 22, 2024 | TE: | AB | RLD: | No | ||||
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