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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219073
Company: UTOPIC PHARMS

Products on ANDA 219073

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219073

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219073

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	215775	DR REDDYS LABS SA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	212317	GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	074910	MYLAN
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	218032	NOVAST LABS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	217377	TWI PHARMS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	219073	UTOPIC PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	215775	DR REDDYS LABS SA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	212317	GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	074910	MYLAN
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	218032	NOVAST LABS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	217377	TWI PHARMS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	219073	UTOPIC PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	215775	DR REDDYS LABS SA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	212317	GLENMARK PHARMS LTD
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	074910	MYLAN
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	218032	NOVAST LABS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	217377	TWI PHARMS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB1	219073	UTOPIC PHARMS

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