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
AMBISOME از شرکت ASTELLAS
New Drug Application (NDA): 050740
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBISOME | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE, LIPOSOMAL;INJECTION | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 08/11/1997 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
PRIORITY; Orphan |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050740_ambisome_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/04/2021 | SUPPL-33 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050740Orig1s033ltr.pdf |
|
| 05/12/2020 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050740Orig1s031ltr.pdf |
||
| 09/16/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/2012 | SUPPL-21 | Labeling-Package Insert |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf |
|
| 10/08/2008 | SUPPL-16 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050740s016ltr.pdf |
||
| 09/16/2003 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50740slr014ltr.pdf |
||
| 09/06/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/2000 | SUPPL-2 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50740S2LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S2_AmBisome.cfm |
||
| 01/28/2000 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/050740s001_ambisome_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/12/2020 | SUPPL-31 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf | |
| 05/12/2020 | SUPPL-31 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf | |
| 03/08/2012 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf |
| 10/08/2008 | SUPPL-16 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050740s016lbl.pdf | |
| 09/16/2003 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50740slr014_ambisome_lbl.pdf | |
| 06/16/2000 | SUPPL-2 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50740S2LBL.PDF | |
| 01/28/2000 | SUPPL-1 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740S001_AmBisome_prntlbl.pdf |
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