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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212880
Company: MICRO LABS

Products on ANDA 212880

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212880Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 212880

COLCHICINE

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	217620	ANNORA PHARMA
COLCHICINE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	No	AB	215463	AUROBINDO PHARMA LTD
COLCHICINE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	No	AB	210757	GRANULES
COLCHICINE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	No	AB	212880	MICRO LABS
COLCHICINE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	No	AB	208678	PH HEALTH
MITIGARE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	Yes	AB	204820	HIKMA INTL PHARMS

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