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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210425


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NDA 210425 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 210425
Tradename:COLCHICINE
Applicant:Granules
Ingredient:colchicine
Patents:0
Pharmacology for NDA: 210425
Medical Subject Heading (MeSH) Categories for 210425
Suppliers and Packaging for NDA: 210425
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLCHICINE colchicine TABLET;ORAL 210425 ANDA Major Pharmaceuticals 0904-7120 0904-7120-04 30 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
COLCHICINE colchicine TABLET;ORAL 210425 ANDA Golden State Medical Supply, Inc. 51407-082 51407-082-01 100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Feb 5, 2020TE:ABRLD:No

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