Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012616
Company: PFIZER
Company: PFIZER
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 | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
12/19/2022 | SUPPL-83 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012616Orig1s083ltr.pdf | |
02/19/2021 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012616Orig1s081ltr.pdf | |
08/20/2020 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012616Orig1s080ltr.pdf | |
01/17/2019 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/012616Orig1s078ltr.pdf | |
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 |
---|---|---|---|---|---|
12/19/2022 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf | |
02/19/2021 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf | |
08/20/2020 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf | |
01/17/2019 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf | |
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 | 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 |