Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206332
Company: NEXUS

Products on ANDA 206332

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	500MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206332

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206332

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	089069	HOSPIRA
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	088636	INTL MEDICATION
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206332	NEXUS

INJECTABLE;INJECTION; 500MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	500MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	089070	HOSPIRA
PROCAINAMIDE HYDROCHLORIDE	PROCAINAMIDE HYDROCHLORIDE	500MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206332	NEXUS