Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087398
Company: WATSON LABS

Products on ANDA 087398

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/1981	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
11/18/1998	SUPPL-23	Labeling		Label is not available on this site.
07/08/1994	SUPPL-21	Labeling		Label is not available on this site.
10/14/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/22/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/06/1991	SUPPL-18	Labeling		Label is not available on this site.
01/28/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/18/1989	SUPPL-14	Labeling		Label is not available on this site.
06/21/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/21/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/21/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/26/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/26/1985	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/04/1985	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.