Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204711
Company: AMNEAL PHARMS

Products on ANDA 204711

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLCHICINE	COLCHICINE	0.6MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204711

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.

Therapeutic Equivalents for ANDA 204711

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	203976	ENDO OPERATIONS
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	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