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
CORLOPAM از شرکت HOSPIRA
New Drug Application (NDA): 019922
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CORLOPAM | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/23/1997 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019922_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/02/2020 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019922s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019922Orig1s019ltr.pdf |
||
12/17/2015 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019922Orig1s016ltr.pdf |
||
03/22/2006 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
04/01/2004 | SUPPL-5 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19922se5-005ltr.pdf |
||
07/06/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/13/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/02/2020 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019922s019lbl.pdf | |
12/17/2015 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf | |
04/01/2004 | SUPPL-5 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf |
CORLOPAM
INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORLOPAM | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019922 | HOSPIRA |
FENOLDOPAM MESYLATE | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077155 | SANDOZ INC |
FENOLDOPAM MESYLATE | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076582 | WEST-WARD PHARMS INT |
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