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
CARDENE SR از شرکت CHIESI
New Drug Application (NDA): 020005
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDENE SR | NICARDIPINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| CARDENE SR | NICARDIPINE HYDROCHLORIDE | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| CARDENE SR | NICARDIPINE HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 02/21/1992 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 08/29/2016 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020005Orig1s014ltr.pdf |
||
| 07/30/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/29/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/20/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2016 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf |
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