اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ALDACTAZIDE از شرکت PFIZER
New Drug Application (NDA): 012616
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 | 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 |
|---|---|---|---|---|---|
| 02/19/2021 | SUPPL-81 | Labeling-Package Insert |
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 |
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 |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf |
||
| 03/06/2014 | SUPPL-75 | Labeling-Package Insert |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf |
|
| 05/19/2011 | SUPPL-68 | Labeling |
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 |
|---|---|---|---|---|---|
| 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 |
نظرات کاربران