← FDA DRUG APPROVALS

FDA ANDA · ANDA206641

TIADYLT ER

diltiazem hydrochloride

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA206641
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-11
LATEST ACTION
2025-06-26
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 420MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-06-26Labeling · Supplement 6 · standardAP
2017-08-11UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →