Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021371
Company: EXELTIS USA INC
Company: EXELTIS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRASORB | ESTRADIOL HEMIHYDRATE | 0.25% | EMULSION;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
10/09/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21371ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-371_Estrasorb.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021371Orig1s010ltr.pdf | |
09/10/2024 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021371Orig1s009ltr.pdf | |
11/01/2017 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf | |
03/10/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021371s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021371Orig1s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/10/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s009lbl.pdf | |
09/10/2024 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s009lbl.pdf | |
02/15/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s010lbl.pdf | |
11/01/2017 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf | |
11/01/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf | |
03/10/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021371s007lbl.pdf | |
10/09/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf |