Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050731
Company: HIKMA

Products on NDA 050731

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	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050731

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50731.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2018	SUPPL-8		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050731Orig1s008Rplacementltr.pdf
06/12/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/02/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/29/1999	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for NDA 050731

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