Details for New Drug Application (NDA): 208970
✉ Email this page to a colleague
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.
Summary for 208970
Tradename: | FELBAMATE |
Applicant: | Zydus Lifesciences |
Ingredient: | felbamate |
Patents: | 0 |
Pharmacology for NDA: 208970
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 208970
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FELBAMATE | felbamate | TABLET;ORAL | 208970 | ANDA | Zydus Lifesciences Limited | 70771-1077 | 70771-1077-1 | 100 TABLET in 1 BOTTLE (70771-1077-1) |
FELBAMATE | felbamate | TABLET;ORAL | 208970 | ANDA | Zydus Lifesciences Limited | 70771-1077 | 70771-1077-3 | 30 TABLET in 1 BOTTLE (70771-1077-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | May 30, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | May 30, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription