Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040326
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
04/21/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40326_Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40326ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040326_estradiol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2019 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
10/14/2009 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/16/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/29/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/21/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40326_Estradiol_Prntlbl.pdf |