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Generated: March 22, 2019

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Details for New Drug Application (NDA): 084279

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NDA 084279 describes COL-PROBENECID, which is a drug marketed by Watson Labs and is included in one NDA. It is available from one supplier. Additional details are available on the COL-PROBENECID profile page.

The generic ingredient in COL-PROBENECID is colchicine; probenecid. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the colchicine; probenecid profile page.
Summary for 084279
Applicant:Watson Labs
Ingredient:colchicine; probenecid
Pharmacology for NDA: 084279
Suppliers and Packaging for NDA: 084279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COL-PROBENECID colchicine; probenecid TABLET;ORAL 084279 ANDA Actavis Pharma, Inc. 0591-5325 0591-5325-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5325-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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