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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050740
Company: ASTELLAS

Products on NDA 050740

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050740

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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 050740

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2021	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050740Orig1s033lbl.pdf
02/04/2021	SUPPL-33	Labeling-Container/Carton Labels	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

Therapeutic Equivalents for NDA 050740

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

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