Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205095
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | AB | No | No |
RUFINAMIDE | RUFINAMIDE | 400MG | 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 |
---|---|---|---|---|---|---|---|
05/16/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/10/2022 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/16/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf |
RUFINAMIDE
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BANZEL | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 021911 | EISAI INC |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 217230 | AUROBINDO PHARMA |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205075 | GLENMARK PHARMS LTD |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204993 | HETERO LABS LTD III |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204988 | HIKMA |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 204964 | LUPIN LTD |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 216688 | MICRO LABS |
RUFINAMIDE | RUFINAMIDE | 200MG | TABLET;ORAL | Prescription | No | AB | 205095 | MYLAN |
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BANZEL | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | Yes | AB | 021911 | EISAI INC |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 217230 | AUROBINDO PHARMA |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 205075 | GLENMARK PHARMS LTD |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204993 | HETERO LABS LTD III |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204988 | HIKMA |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 204964 | LUPIN LTD |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 216688 | MICRO LABS |
RUFINAMIDE | RUFINAMIDE | 400MG | TABLET;ORAL | Prescription | No | AB | 205095 | MYLAN |