Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021065
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEMHRT | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.0025MG;0.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
FEMHRT | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/15/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21065LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLPATIENT.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21065_Femhrt.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/18/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021065Orig1s025,s026ltr.pdf | |
05/18/2023 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021065Orig1s025,s026ltr.pdf | |
11/01/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021065s024lbl.pdf | |
03/25/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/15/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/13/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021065Orig1s020ltr.pdf | |
01/14/2005 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21065s012ltr.pdf | |
01/20/2004 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21065slr009ltr.pdf | |
12/19/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/14/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/14/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/20/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
07/03/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/07/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/18/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf | |
05/18/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021065s025s026lbl.pdf | |
11/01/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021065s024lbl.pdf | |
01/08/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf | |
01/14/2005 | SUPPL-12 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf | |
01/20/2004 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf | |
10/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF |