Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086029
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 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
06/23/1978 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-89 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-88 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-87 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-86 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-84 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-83 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/30/1998 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-81 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/20/1993 SUPPL-80 Labeling

Label is not available on this site.

07/16/1991 SUPPL-79 Labeling

Label is not available on this site.

02/16/1990 SUPPL-78 Labeling

Label is not available on this site.

12/23/1988 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

11/22/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

11/22/1982 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

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