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Details for Generic Name: colchicine

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Colchicine is the generic ingredient in seven branded drugs marketed by Hikma Pharms Llc, Takeda Pharms Usa, Watson Labs, Merck, Beecham, Impax Labs, Ivax Sub Teva Pharms, Mirror Pharms, Sandoz, and Lederle, and is included in twelve NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for colchicine. Eight suppliers are listed for this compound.

Summary for Generic Name: colchicine

Drug Master File Entries: see list13
Suppliers: see list8
Therapeutic Class:Antigout Agents

Pharmacology for Ingredient: colchicine

Clinical Trials for: colchicine

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Status: Completed Condition: Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
TABLET;ORAL022352Jul 29, 2009RXYes8,440,721<disabled><disabled>
colchicine; probenecid
TABLET;ORAL086130Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Takeda Pharms Usa
TABLET;ORAL022352Jul 29, 2009RXYes8,415,396<disabled><disabled>
Watson Labs
colchicine; probenecid
TABLET;ORAL083221Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Impax Labs
colchicine; probenecid
TABLET;ORAL083720Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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