Details for New Drug Application (NDA): 216481
NDA 216481 describes ESLICARBAZEPINE ACETATE, which is a drug marketed by Alkem Labs Ltd, Apotex, Aurobindo Pharma, Dr Reddys, Hetero Labs Ltd V, Jubilant Generics, Lupin, Sph Zhongxi Pharm, and Torrent, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the ESLICARBAZEPINE ACETATE profile page.
The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 216481
| Tradename: | ESLICARBAZEPINE ACETATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | eslicarbazepine acetate |
| Patents: | 0 |
Pharmacology for NDA: 216481
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 216481
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESLICARBAZEPINE ACETATE | eslicarbazepine acetate | TABLET;ORAL | 216481 | ANDA | Aurobindo Pharma Limited | 59651-533 | 59651-533-30 | 30 TABLET in 1 BOTTLE (59651-533-30) |
| ESLICARBAZEPINE ACETATE | eslicarbazepine acetate | TABLET;ORAL | 216481 | ANDA | Aurobindo Pharma Limited | 59651-534 | 59651-534-30 | 30 TABLET in 1 BOTTLE (59651-534-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 5, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Aug 5, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Aug 5, 2026 | TE: | AB | RLD: | No | ||||
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