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
COVERA-HS از شرکت PFIZER
New Drug Application (NDA): 020552
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COVERA-HS | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
No | No |
| COVERA-HS | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/26/1996 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 09/14/2017 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020552s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020552Orig1s010ltr.pdf |
||
| 08/24/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020552Orig1s009ltr.pdf |
|
| 11/02/2011 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020552s007ltr.pdf |
||
| 04/13/2010 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020552s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020552s006ltr.pdf |
||
| 06/29/2009 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020552s005ltr.pdf |
||
| 01/31/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20552slr002ltr.pdf |
|
| 01/13/1998 | 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 |
|---|---|---|---|---|---|
| 09/14/2017 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020552s010lbl.pdf | |
| 11/02/2011 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf | |
| 04/13/2010 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020552s006lbl.pdf | |
| 06/29/2009 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf |
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