An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076468
Company: CIPLA

Products on ANDA 076468

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076468

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/2005/076468ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/29/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/02/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/02/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/24/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/13/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/31/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/31/2010	SUPPL-7	Labeling		Label is not available on this site.
03/20/2013	SUPPL-6	Labeling		Label is not available on this site.
10/23/2008	SUPPL-4	Labeling		Label is not available on this site.
08/28/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076468

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	076468	CIPLA
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	076811	NOVITIUM PHARMA
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	076468	CIPLA
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	076811	NOVITIUM PHARMA
ANAGRELIDE HYDROCHLORIDE	ANAGRELIDE HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	209151	TORRENT

Top