Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086513
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription AB 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
08/03/1979 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
11/06/2019 SUPPL-76 Labeling-Package Insert

Label is not available on this site.

06/14/2016 SUPPL-75 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-73 Labeling-Package Insert

Label is not available on this site.

02/05/2013 SUPPL-68 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/03/2002 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2001 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2000 SUPPL-51 Labeling

Label is not available on this site.

04/21/2000 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1999 SUPPL-49 Labeling

Label is not available on this site.

08/26/1998 SUPPL-48 Labeling

Label is not available on this site.

02/05/1998 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/17/1993 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/09/1993 SUPPL-43 Labeling

Label is not available on this site.

05/30/1991 SUPPL-42 Labeling

Label is not available on this site.

04/04/1990 SUPPL-41 Labeling

Label is not available on this site.

01/31/1990 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/18/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/18/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription Yes AB 012616 PFIZER
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription No AB 086513 MYLAN
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription No AB 089534 SUN PHARM INDUSTRIES

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