Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021813
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELESTRIN | ESTRADIOL | 0.06% (0.87GM/ACTIVATION) | GEL, METERED;TRANSDERMAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
12/15/2006 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021813s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813_elestrin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021813s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021813Orig1s014ltr.pdf | |
10/27/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021813Orig1s007,s009ltr.pdf | |
10/27/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021813Orig1s007,s009ltr.pdf | |
11/01/2017 | SUPPL-6 | Labeling-Patient Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021813s006lbl.pdf | |
02/27/2014 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf | |
02/24/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021813s003ltr.pdf | |
02/26/2008 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021813s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021813s014lbl.pdf | |
10/27/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf | |
10/27/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf | |
11/01/2017 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021813s006lbl.pdf | |
02/27/2014 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf |
02/24/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf | |
12/15/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf |