Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080188
Company: WATSON LABS

Products on ANDA 080188

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080188

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.