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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212514
Company: SPIL

Products on ANDA 212514

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPHOTERICIN B	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212514Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212514

AMPHOTERICIN B

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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