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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084500
Company: BRISTOL MYERS SQUIBB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRACE ESTRADIOL 2MG 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
07/23/1975 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-44 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf
01/25/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
10/05/1998 SUPPL-39 Labeling

Label is not available on this site.
07/28/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
01/08/1997 SUPPL-37 Labeling

Label is not available on this site.
09/11/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
01/19/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
01/19/1995 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.
05/09/1994 SUPPL-31 Labeling

Label is not available on this site.
01/12/1993 SUPPL-30 Labeling

Label is not available on this site.
08/10/1992 SUPPL-29 Labeling

Label is not available on this site.
07/18/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
07/18/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
11/09/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
11/09/1992 SUPPL-24 Labeling

Label is not available on this site.
11/09/1992 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
09/08/1992 SUPPL-22 Labeling

Label is not available on this site.
12/19/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
03/10/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
06/07/1982 SUPPL-14 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-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/081295s014,084499s042,084500s044lbl.pdf
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