Drugs@FDA: FDA Approved Drug Products

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

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

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