Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205049
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.01MG,0.01MG;1MG,N/A | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/31/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205049Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2018 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
11/20/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/31/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205049Orig1lbl.pdf |