Last Updated: June 24, 2026

Details for New Drug Application (NDA): 204461

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NDA 204461 describes COLCHICINE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Granules, Micro Labs, Ph Health, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in seventeen NDAs. It is available from thirty-one suppliers. Additional details are available on the COLCHICINE profile page.

The generic ingredient in COLCHICINE is colchicine. There are sixteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for 204461

Tradename:	COLCHICINE
Applicant:	Watson Labs Inc
Ingredient:	colchicine
Patents:	0

Medical Subject Heading (MeSH) Categories for 204461

Gout Suppressants
Tubulin Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.6MG
Approval Date:	Jul 31, 2019	TE:	AB	RLD:	No

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