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
CAVERJECT IMPULSE از شرکت PFIZER
New Drug Application (NDA): 021212
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAVERJECT IMPULSE | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CAVERJECT IMPULSE | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 06/11/2002 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21212lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-16 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf |
||
| 10/25/2016 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s015,s016ltr.pdf |
||
| 05/05/2016 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021212Orig1s014ltr.pdf |
||
| 12/01/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/2015 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021212s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021212Orig1s011ltr.pdf |
||
| 06/11/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021212Orig1s010ltr.pdf |
|
| 12/19/2013 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021212Orig1s007ltr.pdf |
||
| 09/02/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf | |
| 10/25/2016 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s015s016lbl.pdf | |
| 05/05/2016 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021212s014lbl.pdf | |
| 10/27/2015 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021212s011lbl.pdf | |
| 12/19/2013 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021212s007lbl.pdf | |
| 06/11/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21212lbl.pdf |
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