Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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 SHIRE LLC
ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 076530 BARR
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 PHARMS LTD

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 076530 BARR
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 PHARMS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English