Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217620
Company: ANNORA PHARMA

Products on ANDA 217620

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 217620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2024	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
10/11/2024	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 217620

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