APPLICATION
ANDA206534
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-08
LATEST ACTION
2026-02-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 360MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-02-23Labeling · Supplement 3 · standardAP
2026-02-23Labeling · Supplement 7 · 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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