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
CALAN از شرکت PFIZER
New Drug Application (NDA): 018817
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALAN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| CALAN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| CALAN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
No | No |
| CALAN | VERAPAMIL HYDROCHLORIDE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 09/10/1984 | 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-33 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018817s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018817Orig1s033ltr.pdf |
||
| 08/24/2016 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018817Orig1s032ltr.pdf |
|
| 10/25/2013 | SUPPL-31 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018817Orig1s031ltr.pdf |
||
| 02/13/2013 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2011 | SUPPL-27 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s027ltr.pdf |
||
| 06/29/2011 | SUPPL-24 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s024ltr.pdf |
||
| 04/13/2010 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018817s022ltr.pdf |
||
| 07/09/2009 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018817s021ltr.pdf |
||
| 01/13/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/14/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/04/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/27/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/14/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/13/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/23/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1988 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 06/27/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/06/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/16/1986 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/04/1985 | SUPPL-1 | Manufacturing (CMC)-Formulation |
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-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018817s033lbl.pdf | |
| 10/25/2013 | SUPPL-31 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf | |
| 11/02/2011 | SUPPL-27 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf | |
| 06/29/2011 | SUPPL-24 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf | |
| 04/13/2010 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf | |
| 07/09/2009 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf |
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