Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021166
Company: ASCEND THERAPS US
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 |