Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086881
Company: YAOPHARMA CO LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/10/1980 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
05/09/2001 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1998 SUPPL-43 Labeling

Label is not available on this site.

12/01/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/20/1994 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/23/1990 SUPPL-37 Labeling

Label is not available on this site.

12/27/1990 SUPPL-36 Labeling

Label is not available on this site.

03/31/1989 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/31/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/29/1986 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/29/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/29/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/29/1984 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/11/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/11/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/27/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/27/1983 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/27/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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