Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207707
Company: HIKMA INTL PHARMS

Products on ANDA 207707

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207707

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207707

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; 40MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207707	HIKMA INTL PHARMS
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018132	HOSPIRA

INJECTABLE;INJECTION; 80MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207707	HIKMA INTL PHARMS
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018132	HOSPIRA