Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022501
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LO LOESTRIN FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.01MG,0.01MG;1MG,N/A | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/21/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022501s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501_lo_loestrin_fe_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022501Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022501Orig1s015ltr.pdf | |
10/15/2021 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022501s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022501Orig1s012ltr.pdf | |
10/10/2017 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s009ltr.pdf | |
08/09/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022501Orig1s008ltr.pdf | |
05/08/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/2013 | SUPPL-4 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf | |
04/29/2022 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022501s015lbl.pdf | |
10/15/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022501s012lbl.pdf | |
10/10/2017 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s009lbl.pdf | |
08/09/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022501s008lbl.pdf | |
10/21/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022501s000lbl.pdf |