Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201680
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | AB | No | No |
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/13/2011 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201680s000ltr.pdf |
FELBAMATE
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | No | AB | 204595 | ALVOGEN |
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | No | AB | 201680 | AMNEAL PHARMS |
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | No | AB | 202284 | ANI PHARMS |
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | No | AB | 207093 | TARO |
FELBAMATE | FELBAMATE | 400MG | TABLET;ORAL | Prescription | No | AB | 208970 | ZYDUS LIFESCIENCES |
FELBATOL | FELBAMATE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 020189 | MYLAN SPECIALITY LP |
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | No | AB | 204595 | ALVOGEN |
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | No | AB | 201680 | AMNEAL PHARMS |
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | No | AB | 202284 | ANI PHARMS |
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | No | AB | 207093 | TARO |
FELBAMATE | FELBAMATE | 600MG | TABLET;ORAL | Prescription | No | AB | 208970 | ZYDUS LIFESCIENCES |
FELBATOL | FELBAMATE | 600MG | TABLET;ORAL | Prescription | Yes | AB | 020189 | MYLAN SPECIALITY LP |