Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080188
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE 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
05/02/1974 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-122 Labeling-Package Insert

Label is not available on this site.

10/27/2016 SUPPL-121 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-120 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-119 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-117 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-116 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-113 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/03/1993 SUPPL-112 Labeling

Label is not available on this site.

04/15/1991 SUPPL-111 Labeling

Label is not available on this site.

02/01/1991 SUPPL-110 Labeling

Label is not available on this site.

03/22/1990 SUPPL-109 Labeling

Label is not available on this site.

10/05/1988 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

10/05/1988 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

10/05/1988 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

02/17/1988 SUPPL-105 Labeling

Label is not available on this site.

06/09/1986 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

07/16/1984 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

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