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
ABLAVAR از شرکت LANTHEUS MEDCL
New Drug Application (NDA): 021711
Company: LANTHEUS MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABLAVAR | GADOFOSVESET TRISODIUM | 2440MG/10ML (244MG/ML) | SOLUTION;INTRAVENOUS | Discontinued |
None |
No | No |
| ABLAVAR | GADOFOSVESET TRISODIUM | 3660MG/15ML (244MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/2008 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021711s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2013 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021711Orig1s004ltr.pdf |
||
| 12/20/2010 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s003ltr.pdf |
||
| 01/11/2010 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021711s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/07/2013 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021711s004lbl.pdf | |
| 12/20/2010 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s003lbl.pdf | |
| 01/11/2010 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021711s001lbl.pdf |
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