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
CAM-AP-ES از شرکت CHARTWELL RX
Abbreviated New Drug Application (ANDA): 084897
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CAM-AP-ES | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE | 25MG;15MG;0.1MG | 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 |
---|---|---|---|---|---|---|---|
11/20/1979 | 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 |
---|---|---|---|---|---|
08/20/2020 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
10/06/2000 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/06/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
02/11/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
03/15/1991 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
05/09/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
06/02/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/30/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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