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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204820
Company: HIKMA INTL PHARMS

Medication Guide

Summary Review

Products on NDA 204820

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITIGARE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204820

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204820Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204820Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2018	SUPPL-4		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204820Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204820Orig1s004ltr.pdf

Labels for NDA 204820

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2018	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204820Orig1s004lbl.pdf
09/26/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf

Therapeutic Equivalents for NDA 204820

MITIGARE

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	208678	PAR PHARM INC
MITIGARE	COLCHICINE	0.6MG	CAPSULE;ORAL	Prescription	Yes	AB	204820	HIKMA INTL PHARMS

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