Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065035
Company: MEITHEAL

Products on ANDA 065035

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAUNORUBICIN HYDROCHLORIDE	DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65035ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 065035

DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAUNORUBICIN HYDROCHLORIDE	DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050731	HIKMA
DAUNORUBICIN HYDROCHLORIDE	DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	208759	HISUN PHARM HANGZHOU
DAUNORUBICIN HYDROCHLORIDE	DAUNORUBICIN HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065035	MEITHEAL