Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085603
Company: WATSON LABS

Products on ANDA 085603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE	ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE	2MG/ML;50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/1986	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
02/19/1999	SUPPL-18	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-17	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/15/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/15/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/31/1996	SUPPL-13	Labeling		Label is not available on this site.
04/17/1991	SUPPL-12	Labeling		Label is not available on this site.
03/27/1991	SUPPL-11	Labeling		Label is not available on this site.
07/24/1989	SUPPL-10	Labeling		Label is not available on this site.
12/21/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/14/1988	SUPPL-5	Labeling		Label is not available on this site.
07/17/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/17/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.