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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203976

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NDA 203976 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-four suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for 203976

Tradename:	COLCHICINE
Applicant:	Ph Health
Ingredient:	colchicine
Patents:	0

Pharmacology for NDA: 203976

Medical Subject Heading (MeSH) Categories for 203976

Gout Suppressants
Tubulin Modulators

Suppliers and Packaging for NDA: 203976

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLCHICINE	colchicine	TABLET;ORAL	203976	ANDA	Endo USA, Inc.	49884-171	49884-171-01	100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01)
COLCHICINE	colchicine	TABLET;ORAL	203976	ANDA	Endo USA, Inc.	49884-171	49884-171-11	30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.6MG
Approval Date:	Aug 12, 2021	TE:	AB	RLD:	No

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