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
CIS-PYRO از شرکت SUN PHARM INDS INC
New Drug Application (NDA): 019039
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIS-PYRO | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 06/30/1987 | 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 |
|---|---|---|---|---|---|
| 11/24/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19039s002ltr.pdf |
|
| 05/27/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CIS-PYRO
INJECTABLE;INJECTION; N/A
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIS-PYRO | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 019039 | SUN PHARM INDS INC |
| TECHNESCAN PYP KIT | TECHNETIUM TC-99M PYROPHOSPHATE KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 017538 | CURIUM |
منبع : www.accessdata.fda.gov
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