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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076910
Company: IMPAX LABS

Products on ANDA 076910

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 076910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076910ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/29/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/29/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076910

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

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