Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017948
Company: GD SEARLE LLC
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORMINEST FE | ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE | 0.035MG;0.5MG;75MG | TABLET;ORAL | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017948s047lbl.pdf | |
| 05/08/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017948s046,018926s013lbl.pdf | |
| 08/09/2017 | SUPPL-44 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018926s011,017948s044lbl.pdf |