Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011961
Company: VALIDUS PHARMS INC
Company: VALIDUS PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MARPLAN | ISOCARBOXAZID | 10MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/08/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf | |
| 08/10/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf | |
| 01/12/2005 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf | |
| 08/18/1998 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf |