Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012616
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25MG;25MG TABLET;ORAL Prescription AB Yes No
ALDACTAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 50MG;50MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/1961 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2014 SUPPL-76 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
03/06/2014 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf
01/17/2014 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf
06/12/2013 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf
06/14/2013 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/22/2011 SUPPL-69 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf
05/19/2011 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf
11/26/2002 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1999 SUPPL-62 Labeling

Label is not available on this site.

01/13/1999 SUPPL-61 Labeling

Label is not available on this site.

11/13/1997 SUPPL-58 Labeling

Label is not available on this site.

01/23/1990 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

11/13/1997 SUPPL-37 Labeling

Label is not available on this site.

01/04/1978 SUPPL-16 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/22/2014 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf
03/06/2014 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf
01/17/2014 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf
06/12/2013 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf
05/19/2011 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf

ALDACTAZIDE

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 GD SEARLE LLC
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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