Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091418
Company: SUN PHARM INDS

Products on ANDA 091418

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091418

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091418

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203622	ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	063277	FRESENIUS KABI USA
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209825	GLAND PHARMA LTD
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	062975	HIKMA
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050629	PFIZER
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091495	SAGENT PHARMS
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	091418	SUN PHARM INDS