Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017576
Company: WARNER CHILCOTT LLC
Company: WARNER CHILCOTT LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OVCON-50 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.05MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2008 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017576s051lbl.pdf |