Details for New Drug Application (NDA): 213369
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NDA 213369 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, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-five NDAs. It is available from thirty-three 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. Thirty-six 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. Thirty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 213369
| Tradename: | OXCARBAZEPINE |
| Applicant: | Apotex |
| Ingredient: | oxcarbazepine |
| Patents: | 0 |
Pharmacology for NDA: 213369
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 213369
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 213369 | ANDA | Apotex Corp. | 60505-4128 | 60505-4128-5 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-5) |
| OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 213369 | ANDA | Apotex Corp. | 60505-4128 | 60505-4128-7 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 13, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jul 13, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Jul 13, 2023 | TE: | AB | RLD: | No | ||||
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