Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087265
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/28/1981 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
04/22/1999 SUPPL-29 Labeling

Label is not available on this site.

12/01/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/09/1993 SUPPL-25 Labeling

Label is not available on this site.

04/03/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/23/1991 SUPPL-21 Labeling

Label is not available on this site.

04/16/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/16/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/16/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/16/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-15 Labeling

Label is not available on this site.

10/14/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/31/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/19/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/03/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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