Details for New Drug Application (NDA): 219677
NDA 219677 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Ph Health, Pharmobedient, Rubicon Research, Sciegen Pharms, Torrent, Zydus Pharms, Aurobindo Pharma, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Impax Labs Inc, J Molner, Actavis Totowa, Aiping Pharm Inc, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Ipca Labs, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-four NDAs. It is available from forty-nine suppliers. Additional details are available on the LAMOTRIGINE profile page.
The generic ingredient in LAMOTRIGINE is lamotrigine. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in LAMOTRIGINE is lamotrigine. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 219677
| Tradename: | LAMOTRIGINE |
| Applicant: | Taro |
| Ingredient: | lamotrigine |
| Patents: | 0 |
Pharmacology for NDA: 219677
| Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 219677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 219677 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4252 | 51672-4252-6 | 30 TABLET in 1 BOTTLE (51672-4252-6) |
| LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 219677 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4253 | 51672-4253-6 | 30 TABLET in 1 BOTTLE (51672-4253-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 7, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 7, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 7, 2025 | TE: | AB | RLD: | No | ||||
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