APPLICATION
ANDA218674
TYPE
ANDA
ORIGINAL APPROVAL
2025-02-04
LATEST ACTION
2025-02-04
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCAINAMIDE HYDROCHLORIDEPrescription
PROCAINAMIDE HYDROCHLORIDE 500MG/ML · INJECTABLE · INJECTION
PROCAINAMIDE HYDROCHLORIDEPrescription
PROCAINAMIDE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
2025-02-04UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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