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
CARDIOLITE از شرکت LANTHEUS MEDCL
New Drug Application (NDA): 019785
Company: LANTHEUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDIOLITE | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| MIRALUMA | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Discontinued |
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 |
|---|---|---|---|---|---|---|---|
| 12/21/1990 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 12/04/2019 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019785Orig1s022ltr.pdf |
||
| 04/30/2008 | SUPPL-18 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/019785se5-018_SumR.pdf |
||
| 06/08/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/22/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-6 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-5 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 12/14/1995 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1992 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/30/1992 | 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 |
|---|---|---|---|---|---|
| 12/04/2019 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf | |
| 04/30/2008 | SUPPL-18 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf |
CARDIOLITE
INJECTABLE;INJECTION; N/A
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIOLITE | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Prescription | Yes | AP | 019785 | LANTHEUS MEDCL |
| TECHNETIUM TC 99M SESTAMIBI | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 078809 | CARDINAL HEALTH 414 |
| TECHNETIUM TC 99M SESTAMIBI | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 078098 | CURIUM |
| TECHNETIUM TC 99M SESTAMIBI | TECHNETIUM TC-99M SESTAMIBI KIT | N/A | INJECTABLE;INJECTION | Prescription | No | AP | 078806 | JUBILANT DRAXIMAGE |
MIRALUMA
There are no Therapeutic Equivalents.
نظرات کاربران