Drugs@FDA: FDA Approved Drug Products

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

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