APPLICATION
ANDA075853
TYPE
ANDA
ORIGINAL APPROVAL
2002-12-17
LATEST ACTION
2017-12-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 100MG/VIAL · INJECTABLE · INJECTION
Approval history
2017-12-13Labeling · Supplement 9 · standardAP
2007-01-03Labeling · Supplement 3AP
2002-12-17OriginalAP
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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