Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021633
Company: APIL

Products on NDA 021633

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021633

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

Labels for NDA 021633

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