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Drugs@FDA: FDA-Approved Drugs

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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 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-Container/Carton Labels, Labeling-Package Insert 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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
05/12/2020 SUPPL-31 Labeling-Package Insert 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 212514 SPIL
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