APPLICATION
ANDA074910
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-02
LATEST ACTION
2025-05-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 90MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-05-06Labeling · Supplement 28 · standardAP
2024-09-12Labeling · Supplement 19 · standardAP
2002-10-11Manufacturing (CMC) · Supplement 2AP
2000-11-27Labeling · Supplement 1AP
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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