Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208678
Company: PH HEALTH

Products on ANDA 208678

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 208678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208678Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2025	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/07/2023	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208678

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