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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211519
Company: ZYDUS PHARMS

Products on ANDA 211519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLCHICINE	COLCHICINE	0.6MG	TABLET;ORAL	Prescription	AB	No	No
COLCHICINE	COLCHICINE	0.3MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2020	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-1	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211519Orig1s001ltr.pdf

Therapeutic Equivalents for ANDA 211519

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	203976	PAR PHARM INC
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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