Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081295
Company: BRISTOL MYERS SQUIBB

Products on ANDA 81295

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRACE	ESTRADIOL	0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No

Labels for ANDA 081295

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