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 از شرکت HIKMA INTL PHARMS
Abbreviated New Drug Application (ANDA): 074505
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription |
AB |
No | 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 |
|---|---|---|---|---|---|---|---|
| 02/13/1996 | 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 |
|---|---|---|---|---|---|
| 03/03/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-27 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2011 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CAPTOPRIL
TABLET;ORAL; 12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074737 | ANNORA PHARMA |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074677 | BOSCOGEN |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT LTD |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074737 | ANNORA PHARMA |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074677 | BOSCOGEN |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 25MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT LTD |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074737 | ANNORA PHARMA |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074677 | BOSCOGEN |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 50MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT LTD |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 212809 | AJANTA PHARMA LTD |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074737 | ANNORA PHARMA |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074677 | BOSCOGEN |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074505 | HIKMA INTL PHARMS |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074477 | PRINSTON INC |
| CAPTOPRIL | CAPTOPRIL | 100MG | TABLET;ORAL | Prescription | No | AB | 074532 | WOCKHARDT LTD |
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