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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211076
Company: DR REDDYS

Products on ANDA 211076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2025	SUPPL-6	Labeling-Proprietary Name Change		Label is not available on this site.

Therapeutic Equivalents for ANDA 211076

TRIENTINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SYPRINE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	019194	BAUSCH
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	211076	DR REDDYS
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	209945	ECI PHARMS LLC
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	216356	HETERO LABS LTD III
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	211134	MSN
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	211251	NAVINTA LLC
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	210096	PH HEALTH
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	212238	RISING
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	207567	WATSON LABS TEVA
TRIENTINE HYDROCHLORIDE	TRIENTINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	211554	ZYDUS PHARMS

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