Details for New Drug Application (NDA): 202385
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NDA 202385 describes FELBAMATE, which is a drug marketed by Amneal Pharms, Novitium Pharma, Taro, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the FELBAMATE profile page.
The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 202385
| Tradename: | FELBAMATE |
| Applicant: | Amneal Pharms |
| Ingredient: | felbamate |
| Patents: | 0 |
Pharmacology for NDA: 202385
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 202385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FELBAMATE | felbamate | SUSPENSION;ORAL | 202385 | ANDA | Amneal Pharmaceuticals LLC | 65162-686 | 65162-686-88 | 237 mL in 1 BOTTLE (65162-686-88) |
| FELBAMATE | felbamate | SUSPENSION;ORAL | 202385 | ANDA | Amneal Pharmaceuticals LLC | 65162-686 | 65162-686-90 | 473 mL in 1 BOTTLE (65162-686-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 600MG/5ML | ||||
| Approval Date: | Dec 16, 2011 | TE: | AB | RLD: | No | ||||
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