Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009170
Company: VALEANT
Company: VALEANT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYSOLINE | PRIMIDONE | 250MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MYSOLINE | PRIMIDONE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/2020 | SUPPL-40 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf | |
| 07/21/2010 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf | |
| 07/21/2010 | SUPPL-35 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf | |
| 05/08/2009 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf | |
| 05/08/2009 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf | |
| 04/23/2009 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf |