Drugs@FDA: FDA-Approved Drugs

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

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 PHARMS

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 206332 NEXUS PHARMS

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