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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081295
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.
07/28/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
01/08/1997 SUPPL-7 Labeling

Label is not available on this site.
10/27/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
06/06/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
02/02/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
01/07/1997 SUPPL-3 Labeling

Label is not available on this site.
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
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