Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064103
Company: HIKMA

Products on ANDA 064103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CERUBIDINE	DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1995	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
12/13/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
10/20/1999	SUPPL-9	Labeling		Label is not available on this site.
02/18/1999	SUPPL-8	Labeling		Label is not available on this site.
11/19/1999	SUPPL-7	Labeling		Label is not available on this site.
11/19/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/19/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/19/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/19/1999	SUPPL-3	Manufacturing (CMC)-New Strength		Label is not available on this site.
09/03/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/30/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064103

CERUBIDINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CERUBIDINE	DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064103	HIKMA
DAUNORUBICIN HYDROCHLORIDE	DAUNORUBICIN HYDROCHLORIDE	EQ 20MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065000	FRESENIUS KABI USA