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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216131
Company: SLATE RUN PHARMA

Products on ANDA 216131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216131

DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 12.5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074277	HIKMA
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074086	HOSPIRA
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216131	SLATE RUN PHARMA

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