alcaftadine Ophthalmic Solution

Brand(s)
Lastacaft
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2015-09-30)
Oldest Current Product
2010-11-01
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\ALCAFTADINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\ALCAFTADINE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\ALCAFTADINE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\ALCAFTADINE

product(s) by strength(s)

alcaftadine 2.5 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000234290LastacaftNDAAllergan, Inc.2010-11-01ALCAFTADINEOPHTHALMICSOLUTION/DROPSNDA02213417d37e8d-7825-424b-b6ca-0a85d0bf4694

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540288LastacaftNDARebel Distributors Corp2010-11-01ALCAFTADINEOPHTHALMICSOLUTION/DROPS000234290NDA0221344b8c6afe-2d76-46c7-a23e-99db5e180ff6
2548686294LastacaftNDAPhysicians Total Care, Inc.2011-08-19ALCAFTADINEOPHTHALMICSOLUTION/DROPS000234290NDA022134c192fecc-046d-4905-868f-b8200320309c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022134LASTACAFTALLERGAN INC2010-07-28p8664215, METHOD FOR PREVENTING ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
p5468743, SUBSTANCE
NEW CHEMICAL ENTITY [2015-07-28]NDA022134_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022134_001RXALCAFTADINE (0.25%)OPHTHALMICSOLUTION/DROPSTrue2010-07-28LASTACAFT

patent(s)

#idexpiration dateapplication(s)
1p5468743 (view patent)2016-04-20NDA022134
2p8664215 (view patent)2027-12-23NDA022134

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117d37e8d-7825-424b-b6ca-0a85d0bf4694 (view SPL)These highlights do not include all the information needed to use LASTACAFT safely and effectively. See full prescribing information for LASTACAFT. LASTACAFT (alcaftadine ophthalmic solution)For Topical Ophthalmic UseInitial U.S. Approval: 2010prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2015-09-308000234290
24b8c6afe-2d76-46c7-a23e-99db5e180ff6 (view SPL)These highlights do not include all the information needed to use LASTACAFT safely and effectively. See full prescribing information for LASTACAFT. LASTACAFT (alcaftadine ophthalmic solution) 0.25%Initial U.S. Approval: 2010prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-09-051422540288
3c192fecc-046d-4905-868f-b8200320309c (view SPL)These highlights do not include all the information needed to use LASTACAFT safely and effectively. See full prescribing information for LASTACAFT. LASTACAFT (alcaftadine ophthalmic solution) 0.25%Initial U.S. Approval: 2010prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-09-301548686294

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