Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020130
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTROSTEP 21 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | Yes | No |
ESTROSTEP FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/09/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020130s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020130Orig1s022ltr.pdf | |
07/14/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020130s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020130Orig1s021ltr.pdf | |
10/10/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s018ltr.pdf | |
08/09/2017 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020130Orig1s017ltr.pdf | |
09/03/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/30/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/14/2002 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20130s009ltr.pdf |
03/08/2002 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
07/01/2001 | SUPPL-7 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf | |
03/31/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
10/25/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/07/1999 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20130-s003_Estrostep.pdf |
01/09/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
09/23/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020130s022lbl.pdf | |
07/14/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020130s021lbl.pdf | |
10/10/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s018lbl.pdf | |
08/09/2017 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020130s017lbl.pdf | |
07/01/2001 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20130s7lbl.pdf |