APPLICATION
ANDA202651
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-09
LATEST ACTION
2012-08-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 50MG/10ML · INJECTABLE · INJECTION
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 125MG/25ML · INJECTABLE · INJECTION
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 5MG/ML · INJECTABLE · INJECTION
Approval history
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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