Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040359
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTROPIPATE | ESTROPIPATE | 0.75MG | TABLET;ORAL | Discontinued | None | No | No |
ESTROPIPATE | ESTROPIPATE | 1.5MG | TABLET;ORAL | Discontinued | None | No | No |
ESTROPIPATE | ESTROPIPATE | 3MG | 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 |
---|---|---|---|---|---|---|---|
08/26/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40359ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-6 | Labeling-Patient Package Insert, Labeling, Labeling-Package Insert |
Label is not available on this site. |
||
10/16/2009 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/19/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |