Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202463
Company: ACTAVIS ELIZABETH

Products on ANDA 202463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2025	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/11/2025	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/11/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202463

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB3	020062	BAUSCH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202463	ACTAVIS ELIZABETH
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	216968	ALEMBIC
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	218744	MACLEODS PHARMS LTD
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	208783	NOVAST LABS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	203023	SUN PHARM
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	205231	TWI PHARMS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB3	206534	ZYDUS PHARMS