Colchicine Oral Capsule

Brand(s)
Mitigare
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceutical Corp (2015-02-28)
Oldest Current Product
2014-10-01
License(s)
NDA
RxNORM
ORAL CAPSULE\COLCHICINE
FDAOB
ORAL\CAPSULE\COLCHICINE
SPL Active
ORAL\CAPSULE\COLCHICINE
SPL Moiety
ORAL\CAPSULE\COLCHICINE

product(s) by strength(s)

colchicine 0.6 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001433018NDAWest-Ward Pharmaceutical Corp2014-10-01COLCHICINEORALCAPSULENDA204820ee1583ac-c308-4beb-b602-9ecac4977026

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA204820MITIGAREHIKMA INTERNATIONAL PHARMACEUTICALS LLC2014-09-26p8927607, METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARESNDA204820_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204820_001RXCOLCHICINE (0.6MG)ORALCAPSULEFalse2014-09-26MITIGARE

patent(s)

#idexpiration dateapplication(s)
1p8927607 (view patent)2033-08-22NDA204820

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2 (view SPL)Rx only These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for MITIGARE . MITIGARE (colchicine) capsules Initial U.S. Approval: 1961prescriptionHuman PrescriptionHikma Americas, Inc.2015-07-018594670318
2ee1583ac-c308-4beb-b602-9ecac4977026 (view SPL)Rx Only These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for colchicine capsules. Colchicine capsules Initial U.S. Approval: 1961prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-02-2811001433018

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