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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211250


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NDA 211250 describes COLCHICINE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Ltd, Endo Operations, Granules, 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 211250
Tradename:COLCHICINE
Applicant:Alkem Labs Ltd
Ingredient:colchicine
Patents:0
Pharmacology for NDA: 211250
Medical Subject Heading (MeSH) Categories for 211250
Suppliers and Packaging for NDA: 211250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLCHICINE colchicine TABLET;ORAL 211250 ANDA Bryant Ranch Prepack 63629-8362 63629-8362-1 30 TABLET in 1 BOTTLE (63629-8362-1)
COLCHICINE colchicine TABLET;ORAL 211250 ANDA Bryant Ranch Prepack 63629-8362 63629-8362-2 20 TABLET in 1 BOTTLE (63629-8362-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Feb 8, 2019TE:ABRLD:No

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