Details for New Drug Application (NDA): 212428
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NDA 212428 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 212428
| Tradename: | OXCARBAZEPINE |
| Applicant: | Chartwell Rx |
| Ingredient: | oxcarbazepine |
| Patents: | 0 |
Pharmacology for NDA: 212428
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 212428
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 212428 | ANDA | Chartwell RX, LLC | 62135-841 | 62135-841-24 | 20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45) |
| OXCARBAZEPINE | oxcarbazepine | SUSPENSION;ORAL | 212428 | ANDA | Chartwell RX, LLC | 62135-841 | 62135-841-54 | 250 mL in 1 BOTTLE (62135-841-54) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 300MG/5ML | ||||
| Approval Date: | Jun 21, 2021 | TE: | AB | RLD: | No | ||||
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