Last Updated: June 17, 2026

Details for New Drug Application (NDA): 210633

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NDA 210633 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 210633

Tradename:	COLCHICINE
Applicant:	Macleods Pharms Ltd
Ingredient:	colchicine
Patents:	0

Pharmacology for NDA: 210633

Medical Subject Heading (MeSH) Categories for 210633

Gout Suppressants
Tubulin Modulators

Suppliers and Packaging for NDA: 210633

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLCHICINE	colchicine	TABLET;ORAL	210633	ANDA	Macleods Pharmaceuticals Limited	33342-341	33342-341-07	30 TABLET in 1 BOTTLE (33342-341-07)
COLCHICINE	colchicine	TABLET;ORAL	210633	ANDA	Macleods Pharmaceuticals Limited	33342-341	33342-341-11	100 TABLET in 1 BOTTLE (33342-341-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.6MG
Approval Date:	Feb 13, 2026	TE:	AB	RLD:	No

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