Details for New Drug Application (NDA): 204994
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NDA 204994 describes LACOSAMIDE, which is a drug marketed by Apotex, Aspiro, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Indoco, MSN, Somerset Theraps Llc, Zydus Pharms, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Leading Pharma, Novitium Pharma, Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Glenmark Pharms Ltd, Hetero Labs Ltd V, Kanchan Hlthcare, Macleods Pharms Ltd, Msn Labs Pvt Ltd, Sciegen Pharms Inc, Sun Pharm, and Unichem, and is included in thirty-seven NDAs. It is available from forty-five suppliers. Additional details are available on the LACOSAMIDE profile page.
The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 204994
| Tradename: | LACOSAMIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | lacosamide |
| Patents: | 0 |
Pharmacology for NDA: 204994
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 204994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | lacosamide | TABLET;ORAL | 204994 | ANDA | Aurobindo Pharma Limited | 65862-747 | 65862-747-03 | 3 BLISTER PACK in 1 CARTON (65862-747-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-747-10) |
| LACOSAMIDE | lacosamide | TABLET;ORAL | 204994 | ANDA | Aurobindo Pharma Limited | 65862-747 | 65862-747-60 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-747-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 5, 2023 | TE: | AB | RLD: | No | ||||
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