Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021490
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEMCON FE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
11/14/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21490ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/09/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021490Orig1s019ltr.pdf | |
07/08/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/22/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/03/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/05/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/06/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/22/2016 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021490Orig1s010ltr.pdf | |
01/09/2008 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021490s007ltr.pdf | |
01/29/2007 | SUPPL-5 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021490s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/09/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021490s019lbl.pdf | |
09/22/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021490s010lbl.pdf | |
01/09/2008 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021490s007lbl.pdf | |
01/29/2007 | SUPPL-5 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021490s005lbl.pdf |
11/14/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021490lbl.pdf |