Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209151
Company: TORRENT PHARMS LTD
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
06/30/2017 ORIG-1 Approval STANDARD

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

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