Drugs@FDA: FDA-Approved Drugs
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 | AB | 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 |
Review
|
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-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050740Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050740Orig1s033ltr.pdf | |
05/12/2020 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050740s021ltr.pdf |
10/08/2008 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) Review |
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 |
Label (PDF)
Letter (PDF) Review |
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 |
---|---|---|---|---|---|
02/04/2021 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050740Orig1s033lbl.pdf | |
02/04/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050740Orig1s033lbl.pdf | |
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 |
AMBISOME
INJECTABLE, LIPOSOMAL;INJECTION; 50MG/VIAL
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBISOME | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | Yes | AB | 050740 | ASTELLAS |
AMPHOTERICIN B | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 214010 | EUGIA PHARMA |
AMPHOTERICIN B | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE, LIPOSOMAL;INJECTION | Prescription | No | AB | 212514 | SPIL |