Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081295
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRACE | ESTRADIOL | 0.5MG | 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 |
---|---|---|---|---|---|---|---|
06/30/1993 | 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-14 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf | |
01/25/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/05/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/28/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/08/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/27/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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06/06/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/07/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/07/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/09/1994 | SUPPL-1 | Labeling |
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-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf |