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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204711


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NDA 204711 describes COLCHICINE, which is a drug marketed by Par Pharm Inc, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Granules, Hetero Labs Ltd V, Mylan, Strides Pharma, Watson Labs Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from twenty-five 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-one suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 204711
Tradename:COLCHICINE
Applicant:Amneal Pharms
Ingredient:colchicine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204711
Medical Subject Heading (MeSH) Categories for 204711
Suppliers and Packaging for NDA: 204711
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLCHICINE colchicine TABLET;ORAL 204711 ANDA AvPAK 50268-187 50268-187-15 50 BLISTER PACK in 1 BOX (50268-187-15) / 1 TABLET in 1 BLISTER PACK (50268-187-11)
COLCHICINE colchicine TABLET;ORAL 204711 ANDA Amneal Pharmaceuticals LLC 65162-710 65162-710-03 30 TABLET in 1 BOTTLE (65162-710-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Sep 28, 2016TE:ABRLD:No

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