Colchicine / Probenecid Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2010-06-29)
Oldest Current Product
1982-10-01
License(s)
ANDA
RxNORM
ORAL TABLET\COLCHICINE:PROBENECID
FDAOB
ORAL\TABLET\COLCHICINE: PROBENECID
SPL Active
ORAL\TABLET\COLCHICINE: PROBENECID
SPL Moiety
ORAL\TABLET\COLCHICINE: PROBENECID

product(s) by strength(s)

colchicine 0.5 mg / probenecid 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915325ANDAWatson Laboratories, Inc.1982-10-01COLCHICINE, PROBENECIDORALTABLETANDA084279a0567fe6-132b-463b-bc46-9f5a2a2478fb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910685ANDAAvkare, Inc.2012-05-08COLCHICINE, PROBENECIDORALTABLET649800149ANDA040618ebf556e5-7e01-770c-9dc2-4cdfd661c132

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040618PROBENECID AND COLCHICINEMIRROR PHARMACEUTICALS LLC2008-05-13ANDA040618_001
2ANDA083221PROBENECID W/ COLCHICINETrueWATSON LABORATORIES INCANDA083221_001
3ANDA083720PROBENECID AND COLCHICINETrueIMPAX LABORATORIES INCANDA083720_002
4ANDA083734PROBENECID AND COLCHICINETrueANI PHARMACEUTICALS INCANDA083734_001
5ANDA084279COL-PROBENECIDWATSON LABORATORIES INCANDA084279_001
6ANDA084321PROBENECID AND COLCHICINETrueBEECHAM LABORATORIES DIV BEECHAM INCANDA084321_001
7ANDA085552PROBEN-CTrueWATSON LABORATORIES INCANDA085552_001
8ANDA086130PROBENECID AND COLCHICINETrueSANDOZ INCANDA086130_001
9ANDA086954PROBENECID W/ COLCHICINETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA086954_001
10NDA012383COLBENEMIDTrueMERCK AND CO INCNDA012383_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040618_001RXPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETFalseAB2008-05-13PROBENECID AND COLCHICINE
2ANDA083221_001discontinuedPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETFalsePROBENECID W/ COLCHICINE
3ANDA083720_002discontinuedCOLCHICINE (0.5MG), PROBENECID (500MG)ORALTABLETFalsePROBENECID AND COLCHICINE
4ANDA083734_001discontinuedPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETFalsePROBENECID AND COLCHICINE
5ANDA084279_001RXPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETTrueABCOL-PROBENECID
6ANDA084321_001discontinuedPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETFalsePROBENECID AND COLCHICINE
7ANDA085552_001discontinuedCOLCHICINE (0.5MG), PROBENECID (500MG)ORALTABLETFalsePROBEN-C
8ANDA086130_001discontinuedCOLCHICINE (0.5MG), PROBENECID (500MG)ORALTABLETFalsePROBENECID AND COLCHICINE
9ANDA086954_001discontinuedPROBENECID (500MG), COLCHICINE (0.5MG)ORALTABLETFalsePROBENECID W/ COLCHICINE
10NDA012383_001discontinuedCOLCHICINE (0.5MG), PROBENECID (500MG)ORALTABLETFalseCOLBENEMID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a0567fe6-132b-463b-bc46-9f5a2a2478fb (view SPL)Probenecid and ColchicineTablets USP Revised: June 2009Rx only190813prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-06-292005915325
2ebf556e5-7e01-770c-9dc2-4cdfd661c132 (view SPL)Probenecid and ColchicineTablets USP 500mg/0.5mgprescriptionHuman PrescriptionAvkare, Inc.2012-05-103422910685

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII