Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203110
Company: ADRASTEA PHARMA

Products on ANDA 203110

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203110

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203110Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203110

HYDRALAZINE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203110	ADRASTEA PHARMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040136	AM REGENT
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215147	EUGIA PHARMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040388	FRESENIUS KABI USA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	213667	HIKMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	202938	NAVINTA LLC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040730	RISING