FDA.reportPublic FDA data

Application 206214

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1686WAL-ITINLORATADINEWALGREENSANDACurrent
0363-1686WAL-ITINLORATADINEWALGREENSANDACurrent
0363-1686WAL-ITINLORATADINEWALGREENSANDACurrent
11673-986ALLERGY RELIEFLORATADINETARGET CORPORATIONANDACurrent
11673-986ALLERGY RELIEFLORATADINETARGET CORPORATIONANDACurrent
11673-986ALLERGY RELIEFLORATADINETARGET CORPORATIONANDACurrent
11822-0713Allergy ReliefLoratadineRITE AIDANDACurrent
21130-195Allergy ReliefLoratadineSafewayANDACurrent
25000-021LoratadineLoratadineMARKSANS PHARMA LIMITEDANDACurrent
25000-021loratadineloratadineMARKSANS PHARMA LIMITEDANDACurrent
36800-965Allergy ReliefLoratadineTopCareANDACurrent
36800-965Allergy ReliefLoratadineTopCareANDACurrent
41226-686LORATADINELORATADINEKROGER COMPANYANDACurrent
49035-686LORATADINE SOFTGELSLoratadineWal-Mart Stores IncANDACurrent
49483-686LORATADINELORATADINETIME CAP LABORATORIES INCANDACurrent
49738-686LORATADINELORATADINESMART SENSE (KMART)ANDACurrent
50804-840Allergy ReliefLoratadineGOODSENSEANDACurrent
50804-840Allergy ReliefLoratadineGOODSENSEANDACurrent
63868-669Allergy ReliefloratadineCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
68016-055Allergy ReliefLoratadineCHAIN DRUG CONSORTIUMANDACurrent
69842-686LORATADINELORATADINECVS HEALTH CORPANDACurrent
69842-686LORATADINELORATADINECVS HEALTH CORPANDACurrent
69842-686LORATADINELORATADINECVS HEALTH CORPANDACurrent
70000-0217LORATADINELORATADINECardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45611ORIG2016-10-12
45481ORIG2016-09-27