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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204711
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLCHICINE COLCHICINE 0.6MG TABLET;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
09/28/2016 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/23/2021 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

COLCHICINE

TABLET;ORAL; 0.6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 211250 ALKEM LABS LTD
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 204711 AMNEAL PHARMS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 215444 AUROBINDO PHARMA LTD
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 209876 DR REDDYS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 210425 GRANULES
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 208993 HETERO LABS LTD V
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 209470 MYLAN
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 209173 STRIDES PHARMA
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 204461 WATSON LABS INC
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 211519 ZYDUS PHARMS
COLCRYS COLCHICINE 0.6MG TABLET;ORAL Prescription Yes AB 022352 TAKEDA PHARMS USA
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