Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016119
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESLAC TESTOLACTONE 100MG/ML INJECTABLE;INJECTION 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
06/03/1969 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/27/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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