Details for New Drug Application (NDA): 209301
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 209301
Tradename: | LACOSAMIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209301
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209301
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 209301 | ANDA | Camber Pharmaceuticals, Inc. | 31722-627 | 31722-627-26 | 1 BOTTLE in 1 CARTON (31722-627-26) / 200 mL in 1 BOTTLE |
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 209301 | ANDA | Camber Pharmaceuticals, Inc. | 31722-627 | 31722-627-46 | 1 BOTTLE in 1 CARTON (31722-627-46) / 465 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
Approval Date: | May 31, 2022 | TE: | AA | RLD: | No |
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