Drugs@FDA: FDA-Approved Drugs
Company: BRISTOL MYERS SQUIBB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRACE | ESTRADIOL | 1MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
07/28/1975 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2005 | SUPPL-42 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf | |
01/25/2001 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/05/1998 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
07/28/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
09/11/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1995 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1995 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
01/12/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
08/10/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
06/30/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
11/09/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/08/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
12/19/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/10/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/12/2005 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf |