Details for New Drug Application (NDA): 204595
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The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Pharmacology for NDA: 204595
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 204595
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FELBAMATE | felbamate | TABLET;ORAL | 204595 | ANDA | Alvogen Inc. | 47781-627 | 47781-627-01 | 100 TABLET in 1 BOTTLE (47781-627-01) |
FELBAMATE | felbamate | TABLET;ORAL | 204595 | ANDA | Alvogen Inc. | 47781-630 | 47781-630-01 | 100 TABLET in 1 BOTTLE (47781-630-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No |
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