Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062921
Company: HIKMA

Products on ANDA 062921

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/1989	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2018	SUPPL-26	Labeling-Container/Carton Labels		Label is not available on this site.
07/25/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf
11/18/2010	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/15/2007	SUPPL-18	Labeling		Label is not available on this site.
07/28/2003	SUPPL-15	Labeling		Label is not available on this site.
09/19/2000	SUPPL-14	Labeling		Label is not available on this site.
08/24/1999	SUPPL-13	Labeling		Label is not available on this site.
12/01/1998	SUPPL-12	Labeling		Label is not available on this site.
04/30/1997	SUPPL-11	Labeling		Label is not available on this site.
07/29/1996	SUPPL-10	Labeling		Label is not available on this site.
02/24/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/24/1995	SUPPL-8	Labeling		Label is not available on this site.
11/16/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/28/1993	SUPPL-6	Labeling		Label is not available on this site.
10/31/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/27/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/08/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/03/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/05/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 062921

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062921s022lbl.pdf

Therapeutic Equivalents for ANDA 062921

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208888	AMNEAL
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062921	HIKMA

INJECTABLE;INJECTION; 50MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208888	AMNEAL
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062921	HIKMA
DOXORUBICIN HYDROCHLORIDE	DOXORUBICIN HYDROCHLORIDE	50MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200170	MYLAN LABS LTD