Colchicine Oral Tablet

Brand(s)
Colcrys
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2014-10-28)
Oldest Current Product
2009-09-01
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
ORAL TABLET\COLCHICINE
FDAOB
ORAL\TABLET\COLCHICINE
SPL Active
ORAL\TABLET, FILM COATED\COLCHICINE
SPL Moiety
ORAL\TABLET, FILM COATED\COLCHICINE

product(s) by strength(s)

colchicine 0.6 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640119ColcrysNDATakeda Pharmaceuticals America, Inc.2009-09-01COLCHICINEORALTABLET, FILM COATEDNDA02235256c130d1-7581-4152-99a2-0014ee9366c0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1669930165NDA AUTHORIZED GENERICPrasco Laboratories2015-01-12COLCHICINEORALTABLET, FILM COATEDNDA022352153f5af8-827e-4a58-a0bd-5aafcb3b5444

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1433530854ColcrysNDAAphena Pharma Solutions - Tennessee, Llc2009-09-01COLCHICINEORALTABLET, FILM COATED647640119NDA022352a80036fe-3016-4541-aa42-6c06cf37ae55
2521250083ColcrysNDARemedyrepack Inc.2013-02-21COLCHICINEORALTABLET, FILM COATED133100119NDA02235295a7ff27-b165-436a-b160-7a0f8ec95d7d
3521250259ColcrysNDARemedyrepack Inc.2013-05-03COLCHICINEORALTABLET, FILM COATED133100119NDA022352a0688f33-f00f-4a68-abc3-73ec887a471a
4548686256ColcrysNDAPhysicians Total Care, Inc.2011-10-19COLCHICINEORALTABLET, FILM COATED133100119NDA0223524e936802-5b5d-4772-8b1d-4f30867ffa59
5551545157ColcrysNDACardinal Health2009-09-01COLCHICINEORALTABLET, FILM COATED647640119NDA022352847af9a9-57e3-4474-99ab-89cd0380f125
6631870292ColcrysNDAProficient Rx Lp2009-09-01COLCHICINEORALTABLET, FILM COATED647640119NDA022352d6adc880-5499-4691-93f3-27c87902d5fc

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022352COLCRYSTAKEDA PHARMACEUTICALS USA INC2009-07-29p8097655, METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
p7935731, METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
p8415395, METHOD OF TREATING GOUT FLARES
p7906519, METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
p8093297, FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
p8093296, METHOD OF TREATING GOUT FLARES
p8440721, METHOD OF TREATING GOUT FLARES
p8093298, METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
p8440722, METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
p7981938, A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS
p7619004, METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
p8415396, METHOD OF TREATING GOUT FLARES
p7915269, METHOD OF TREATING GOUT FLARES
p7964648, FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER
p7601758, METHOD OF TREATING GOUT FLARES
p7964647, METHOD OF TREATING GOUT FLARES
p7820681, METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
ORPHAN DRUG EXCLUSIVITY [2016-07-29]NDA022352_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022352_001RXCOLCHICINE (0.6MG)ORALTABLETTrue2009-07-29COLCRYS

patent(s)

#idexpiration dateapplication(s)
1p7601758 (view patent)2029-02-10NDA022352
2p7619004 (view patent)2028-12-03NDA022352
3p7820681 (view patent)2029-02-17NDA022352
4p7906519 (view patent)2029-02-17NDA022352
5p7915269 (view patent)2029-02-17NDA022352
6p7935731 (view patent)2028-12-03NDA022352
7p7964647 (view patent)2028-10-06NDA022352
8p7964648 (view patent)2028-10-06NDA022352
9p7981938 (view patent)2028-10-06NDA022352
10p8093296 (view patent)2028-10-06NDA022352
11p8093297 (view patent)2028-10-06NDA022352
12p8093298 (view patent)2028-10-06NDA022352
13p8097655 (view patent)2028-10-06NDA022352
14p8415395 (view patent)2028-10-06NDA022352
15p8415396 (view patent)2028-10-06NDA022352
16p8440721 (view patent)2029-02-17NDA022352
17p8440722 (view patent)2029-02-17NDA022352

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1153f5af8-827e-4a58-a0bd-5aafcb3b5444 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for Colchicine Tablets, USP. Colchicine Tablets, USP, for oral useInitial U.S. Approval: 1961prescriptionHuman PrescriptionPrasco Laboratories2015-04-212669930165
24e936802-5b5d-4772-8b1d-4f30867ffa59 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-242548686256
356c130d1-7581-4152-99a2-0014ee9366c0 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets, for oral useInitial U.S. Approval: 1961prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2014-10-285647640119
45ecaa34e-1bed-49a5-b97c-a8f8c0d885a7 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961prescriptionHuman PrescriptionAr Scientific, Inc.2012-03-1514133100119
5847af9a9-57e3-4474-99ab-89cd0380f125 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets, for oral useInitial U.S. Approval: 1961prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-103551545157
695a7ff27-b165-436a-b160-7a0f8ec95d7d (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-212521250083
7a0688f33-f00f-4a68-abc3-73ec887a471a (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-031521250259
8a80036fe-3016-4541-aa42-6c06cf37ae55 (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets for Oral useInitial U.S. Approval: 1961prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-04-231433530854
9d6adc880-5499-4691-93f3-27c87902d5fc (view SPL)These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS. COLCRYS (colchicine, USP) tablets, for oral useInitial U.S. Approval: 1961prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-11-011631870292

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