Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 016118

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/1970	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2003	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16118slr023_teslac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16118slr023ltr.pdf
03/22/2001	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/25/1999	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/24/1999	SUPPL-20	Labeling		Label is not available on this site.
08/28/1995	SUPPL-19	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/09/1992	SUPPL-18	Labeling		Label is not available on this site.
10/10/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/30/1986	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/03/1985	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-14	Labeling		Label is not available on this site.
04/27/1979	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
10/11/1979	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1978	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/16/1978	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
06/22/1976	SUPPL-9	Unspecified		Label is not available on this site.
05/06/1976	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.

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