Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021633
Company: APIL
Company: APIL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEMTRACE | ESTRADIOL ACETATE | 0.45MG | TABLET;ORAL | Discontinued | None | Yes | No |
FEMTRACE | ESTRADIOL ACETATE | 0.9MG | TABLET;ORAL | Discontinued | None | Yes | No |
FEMTRACE | ESTRADIOL ACETATE | 1.8MG | 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 |
---|---|---|---|---|---|---|---|
08/20/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21633ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021633s000_FemtraceTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/01/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021633s006lbl.pdf | |
08/12/2014 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021633s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021633Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/01/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021633s006lbl.pdf | |
08/12/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021633s005lbl.pdf |