An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203622
Company: ACTAVIS INC

Products on ANDA 203622

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
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203622

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2014	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203622

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

INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	203622	ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	064097	HIKMA
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	200MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050629	PFIZER

Top