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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 204711

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NDA 204711 describes COLCHICINE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Granules, Ph Health, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-seven 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-two suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for 204711

Tradename:	COLCHICINE
Applicant:	Amneal Pharms
Ingredient:	colchicine
Patents:	0

Pharmacology for NDA: 204711

Medical Subject Heading (MeSH) Categories for 204711

Gout Suppressants
Tubulin Modulators

Suppliers and Packaging for NDA: 204711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLCHICINE	colchicine	TABLET;ORAL	204711	ANDA	AvPAK	50268-187	50268-187-15	50 BLISTER PACK in 1 BOX (50268-187-15) / 1 TABLET in 1 BLISTER PACK (50268-187-11)
COLCHICINE	colchicine	TABLET;ORAL	204711	ANDA	Amneal Pharmaceuticals LLC	65162-710	65162-710-03	30 TABLET in 1 BOTTLE (65162-710-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.6MG
Approval Date:	Sep 28, 2016	TE:	AB	RLD:	No

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