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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207228
Company: AYANA PHARMA LTD

Products on ANDA 207228

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	AB	No	No
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207228

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

INJECTABLE, LIPOSOMAL;INJECTION; 20MG/10ML (2MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	Yes	AB	050718	BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	207228	AYANA PHARMA LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	212219	BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	208657	DR REDDYS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	203263	SUN PHARM
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	20MG/10ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	212299	ZYDUS LIFESCIENCES

INJECTABLE, LIPOSOMAL;INJECTION; 50MG/25ML (2MG/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXIL (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	Yes	AB	050718	BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	207228	AYANA PHARMA LTD
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	212219	BAXTER HLTHCARE CORP
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	208657	DR REDDYS
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	203263	SUN PHARM
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE	50MG/25ML (2MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AB	212299	ZYDUS LIFESCIENCES

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