Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087086
Company: MYLAN

Products on ANDA 087086

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1981	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
09/13/2000	SUPPL-27	Labeling		Label is not available on this site.
04/03/2000	SUPPL-26	Labeling		Label is not available on this site.
08/26/1998	SUPPL-25	Labeling		Label is not available on this site.
02/05/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/25/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/01/1994	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/01/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/01/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/16/1993	SUPPL-19	Labeling		Label is not available on this site.
12/26/1990	SUPPL-17	Labeling		Label is not available on this site.
01/31/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/10/1987	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/17/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/10/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/18/1984	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/02/1981	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.