Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006035
Company: EDISON THERAPS LLC
Company: EDISON THERAPS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHERGINE | METHYLERGONOVINE MALEATE | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
METHERGINE | METHYLERGONOVINE MALEATE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/25/2012 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf | |
04/26/2007 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf |