Details for New Drug Application (NDA): 213183
✉ Email this page to a colleague
NDA 213183 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, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-six NDAs. It is available from thirty-two 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-five 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-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 213183
| Tradename: | OXCARBAZEPINE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | oxcarbazepine |
| Patents: | 0 |
Pharmacology for NDA: 213183
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 213183
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 213183 | ANDA | Ascend Laboratories, LLC | 67877-532 | 67877-532-58 | 250 mL in 1 BOTTLE (67877-532-58) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
| Approval Date: | Mar 18, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
