Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089534
Company: SUN PHARM INDUSTRIES
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
07/02/1987 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
11/01/2019 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

09/24/2014 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

12/14/2011 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

12/14/2011 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

01/31/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2001 SUPPL-18 Labeling

Label is not available on this site.

12/10/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

02/01/2000 SUPPL-14 Labeling

Label is not available on this site.

07/28/1998 SUPPL-13 Labeling

Label is not available on this site.

12/05/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/01/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-9 Labeling

Label is not available on this site.

06/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/05/1995 SUPPL-6 Labeling

Label is not available on this site.

10/15/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/02/1993 SUPPL-4 Labeling

Label is not available on this site.

10/15/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/09/1991 SUPPL-2 Labeling

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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