Details for New Drug Application (NDA): 078009
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NDA 078009 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, 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-one NDAs. It is available from fifty-two suppliers. Additional details are available on the LAMOTRIGINE profile page.
The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 078009
| Tradename: | LAMOTRIGINE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | lamotrigine |
| Patents: | 0 |
Pharmacology for NDA: 078009
| 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: 078009
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 078009 | ANDA | Zydus Lifesciences Limited | 65841-689 | 65841-689-01 | 100 TABLET, CHEWABLE in 1 BOTTLE (65841-689-01) |
| LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 078009 | ANDA | Zydus Lifesciences Limited | 65841-689 | 65841-689-05 | 500 TABLET, CHEWABLE in 1 BOTTLE (65841-689-05) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 22, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 25MG | ||||
| Approval Date: | Jan 22, 2009 | TE: | AB | RLD: | No | ||||
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