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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215463

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NDA 215463 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 215463

Tradename:	COLCHICINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	colchicine
Patents:	0

Pharmacology for NDA: 215463

Medical Subject Heading (MeSH) Categories for 215463

Gout Suppressants
Tubulin Modulators

Suppliers and Packaging for NDA: 215463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLCHICINE	colchicine	CAPSULE;ORAL	215463	ANDA	Aurobindo Pharma Limited	59651-446	59651-446-01	100 CAPSULE in 1 BOTTLE (59651-446-01)
COLCHICINE	colchicine	CAPSULE;ORAL	215463	ANDA	Aurobindo Pharma Limited	59651-446	59651-446-30	30 CAPSULE in 1 BOTTLE (59651-446-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.6MG
Approval Date:	Apr 29, 2024	TE:	AB	RLD:	No

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