Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016118
Company: BRISTOL MYERS SQUIBB

Products on NDA 16118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESLAC	TESTOLACTONE	50MG	TABLET;ORAL	Discontinued	None	No	No
TESLAC	TESTOLACTONE	250MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 016118

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2003	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16118slr023_teslac_lbl.pdf