Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086417
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 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
07/07/1983 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-27 Labeling-Package Insert

Label is not available on this site.

10/27/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/14/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

08/04/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/07/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/20/1992 SUPPL-15 Labeling

Label is not available on this site.

05/24/1991 SUPPL-14 Labeling

Label is not available on this site.

11/02/1989 SUPPL-13 Labeling

Label is not available on this site.

01/10/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/02/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/11/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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