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
CAPTOPRIL AND HYDROCHLOROTHIAZIDE از شرکت IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 075055
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET;ORAL | Discontinued |
None |
No | No |
CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET;ORAL | Discontinued |
None |
No | No |
CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET;ORAL | Discontinued |
None |
No | No |
CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET;ORAL | Discontinued |
None |
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 |
---|---|---|---|---|---|---|---|
06/18/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75055ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/29/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/12/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
11/07/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/13/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
04/13/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
04/13/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/28/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/23/1999 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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