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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021166
Company: ASCEND THERAPS US

Products on NDA 021166

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTROGEL	ESTRADIOL	0.06%	GEL;TOPICAL	Discontinued	None	No	No
ESTROGEL	ESTRADIOL	0.06% (1.25GM/ACTIVATION)	GEL, METERED;TRANSDERMAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021166

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21166_EstrogelTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021166s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021166Orig1s019ltr.pdf
08/01/2023	SUPPL-18	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021166Orig1s018ltr.pdf
11/30/2021	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021166Orig1s017ltr.pdf
11/01/2017	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf
06/11/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/14/2012	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/25/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021166Orig1s010ltr.pdf
01/25/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021166s007ltr.pdf
07/25/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021166s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021166s005_ltr.pdf
10/04/2006	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
09/13/2004	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21166s001ltr.pdf

Labels for NDA 021166

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021166s019lbl.pdf
02/15/2024	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021166s019lbl.pdf
08/01/2023	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf
08/01/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf
11/30/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf
11/30/2021	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf
11/01/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf
11/01/2017	SUPPL-15	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf
03/25/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021166s010lbl.pdf
01/25/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021166s007lbl.pdf
07/25/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021166s005lbl.pdf
02/09/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21166_estrogel_lbl.pdf

Therapeutic Equivalents for NDA 021166

ESTROGEL

GEL, METERED;TRANSDERMAL; 0.06% (1.25GM/ACTIVATION)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.06% (1.25GM/ACTIVATION)	GEL, METERED;TRANSDERMAL	Prescription	No	AB	216160	SOLARIS PHARMA CORP
ESTROGEL	ESTRADIOL	0.06% (1.25GM/ACTIVATION)	GEL, METERED;TRANSDERMAL	Prescription	Yes	AB	021166	ASCEND THERAPS US

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