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-MDP از شرکت SUN PHARM INDS INC
New Drug Application (NDA): 018124
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIS-MDP | TECHNETIUM TC-99M MEDRONATE KIT | N/A | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1979 | 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 |
|---|---|---|---|---|---|
| 05/17/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2005 | SUPPL-13 | Manufacturing (CMC)-Control |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf |
||
| 05/27/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/02/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1984 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/27/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/18/1988 | 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 |
|---|---|---|---|---|---|
| 04/19/2005 | SUPPL-13 |
Manufacturing (CMC)-Control |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf |
نظرات کاربران