Details for New Drug Application (NDA): 211227
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NDA 211227 describes ESLICARBAZEPINE ACETATE, which is a drug marketed by Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Sph Zhongxi Pharm, and Torrent, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the ESLICARBAZEPINE ACETATE profile page.
The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Eight 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 are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 211227
| Tradename: | ESLICARBAZEPINE ACETATE |
| Applicant: | Torrent |
| Ingredient: | eslicarbazepine acetate |
| Patents: | 0 |
Pharmacology for NDA: 211227
| 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: 211227
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESLICARBAZEPINE ACETATE | eslicarbazepine acetate | TABLET;ORAL | 211227 | ANDA | Torrent Pharmaceuticals Limited | 13668-538 | 13668-538-05 | 500 TABLET in 1 BOTTLE (13668-538-05) |
| ESLICARBAZEPINE ACETATE | eslicarbazepine acetate | TABLET;ORAL | 211227 | ANDA | Torrent Pharmaceuticals Limited | 13668-538 | 13668-538-30 | 30 TABLET in 1 BOTTLE (13668-538-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 27, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Feb 27, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Feb 27, 2024 | TE: | AB | RLD: | No | ||||
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