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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074910
Company: MYLAN

Products on ANDA 074910

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/1997	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074910_diltiazem_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2025	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/12/2024	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/11/2002	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/27/2000	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074910

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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