Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011909
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NARDIL | PHENELZINE SULFATE | EQ 15MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/02/2007 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf | |
| 02/06/2007 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf | |
| 02/06/2007 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf | |
| 09/02/2003 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf |