Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021633
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

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