Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211251
Company: NAVINTA LLC

Products on ANDA 211251

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 211251

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211251

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	210096	ENDO OPERATIONS
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	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