Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088342
Company: UPSHER SMITH LABS

Products on ANDA 088342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXYMESTERONE	FLUOXYMESTERONE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1983	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
04/06/1992	SUPPL-25	Labeling		Label is not available on this site.
12/11/1991	SUPPL-24	Labeling		Label is not available on this site.
07/02/1991	SUPPL-22	Labeling		Label is not available on this site.
03/08/1990	SUPPL-21	Labeling		Label is not available on this site.
11/07/1989	SUPPL-20	Labeling		Label is not available on this site.
01/12/1989	SUPPL-19	Labeling		Label is not available on this site.
12/26/1987	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/26/1988	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
09/17/1986	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/17/1986	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/17/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/20/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/27/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/17/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/17/1984	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/17/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/17/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.