APPLICATION
ANDA203023
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-08
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 360MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-07-10Labeling · Supplement 12 · standardAP
2023-05-08Labeling · Supplement 10 · standardAP
2017-06-08UNKNOWN · OriginalAP
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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