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
CORVERT از شرکت PFIZER
New Drug Application (NDA): 020491
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORVERT | IBUTILIDE FUMARATE | 0.1MG/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 |
|---|---|---|---|---|---|---|---|
| 12/28/1995 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020491Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/09/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/2001 | SUPPL-3 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf |
||
| 04/03/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s002_Corvert.pdf |
|
| 05/13/1999 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20491s01lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s01ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20491s001.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/20/2001 | SUPPL-3 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf | |
| 05/13/1999 | SUPPL-1 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20491s01lbl.pdf |
CORVERT
INJECTABLE;INJECTION; 0.1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CORVERT | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020491 | PFIZER |
| IBUTILIDE FUMARATE | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090643 | MYLAN INSTITUTIONAL |
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