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Last Updated: April 17, 2026

Details for New Drug Application (NDA): 212880

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NDA 212880 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 twenty-eight 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-three suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for 212880

Tradename:	COLCHICINE
Applicant:	Micro Labs
Ingredient:	colchicine
Patents:	0

Pharmacology for NDA: 212880

Medical Subject Heading (MeSH) Categories for 212880

Gout Suppressants
Tubulin Modulators

Suppliers and Packaging for NDA: 212880

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLCHICINE	colchicine	CAPSULE;ORAL	212880	ANDA	Micro Labs Limited	42571-341	42571-341-01	100 CAPSULE in 1 BOTTLE (42571-341-01)
COLCHICINE	colchicine	CAPSULE;ORAL	212880	ANDA	Micro Labs Limited	42571-341	42571-341-10	1000 CAPSULE in 1 BOTTLE (42571-341-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.6MG
Approval Date:	Feb 17, 2026	TE:	AB	RLD:	No

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