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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021166
Company: ASCEND THERAPS US
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
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-Package Insert, Labeling-Patient 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-Patient Package Insert, Labeling-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-Patient Package Insert, Labeling-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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf
08/01/2023 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021166s018lbl.pdf
11/30/2021 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf
11/30/2021 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021166s017lbl.pdf
11/01/2017 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021166s015lbl.pdf
11/01/2017 SUPPL-15 Labeling-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

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 217882 NOVITIUM PHARMA
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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