Drugs@FDA: FDA-Approved Drugs
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FELBATOL | FELBAMATE | 400MG | TABLET;ORAL | Prescription | AB | Yes | No |
FELBATOL | FELBAMATE | 600MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
FELBATOL | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/29/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2012 | SUPPL-27 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020189Orig1s027ltr.pdf | |
07/06/2011 | SUPPL-23 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020189s023ltr.pdf | |
04/23/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020189s022ltr.pdf | |
06/26/2002 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/2002 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20189slr018ltr.pdf |
08/28/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/26/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/24/1995 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
11/29/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
11/01/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/01/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/31/1994 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
03/02/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/21/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/20/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/17/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/31/2012 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf | |
07/06/2011 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf | |
07/06/2011 | SUPPL-23 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020189s023lbl.pdf | |
04/23/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf |
FELBATOL
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 |
SUSPENSION;ORAL; 600MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 202385 | AMNEAL PHARMS |
FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 211333 | NOVITIUM PHARMA |
FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 206314 | TARO |
FELBATOL | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 020189 | MYLAN SPECIALITY LP |