Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020189
Company: MYLAN SPECIALITY LP
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 |
| 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 |