Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209151
Company: TORRENT

Products on ANDA 209151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209151

ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AGRYLIN	ANAGRELIDE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	020333	TAKEDA PHARMS USA
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	076910	IMPAX LABS
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	076468	IVAX SUB TEVA PHARMS
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	209151	TORRENT

CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	076910	IMPAX LABS
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	076468	IVAX SUB TEVA PHARMS
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	209151	TORRENT