Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065000
Company: FRESENIUS KABI USA

Products on ANDA 065000

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65000ltr.pdf

Therapeutic Equivalents for ANDA 065000

DAUNORUBICIN HYDROCHLORIDE

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