Details for New Drug Application (NDA): 211333
✉ 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 211333
Tradename: | FELBAMATE |
Applicant: | Novitium Pharma |
Ingredient: | felbamate |
Patents: | 0 |
Pharmacology for NDA: 211333
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 211333
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FELBAMATE | felbamate | SUSPENSION;ORAL | 211333 | ANDA | Novitium Pharma LLC | 70954-051 | 70954-051-10 | 237 mL in 1 BOTTLE (70954-051-10) |
FELBAMATE | felbamate | SUSPENSION;ORAL | 211333 | ANDA | Novitium Pharma LLC | 70954-051 | 70954-051-20 | 473 mL in 1 BOTTLE (70954-051-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 600MG/5ML | ||||
Approval Date: | May 31, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription