FDA.reportPublic FDA data

Application 210088

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINETABLET, CHEWABLE;ORAL5MGNoNo
002LORATADINELORATADINETABLET, CHEWABLE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0752LoratadineLoratadineWALGREEN COMPANYANDACurrent
0363-0754Wal-itinLORATADINEWalgreensANDACurrent
0363-9994LoratadineLoratadineWALGREENS CO.ANDACurrent
0363-9994LoratadineLoratadineWALGREENS CO.ANDACurrent
0363-9994LoratadineLoratadineWALGREENS CO.ANDACurrent
0363-9995Wal-itinLORATADINEWALGREENS CO.ANDACurrent
0363-9995Wal-itinLORATADINEWALGREENS CO.ANDACurrent
0363-9995Wal-itinLORATADINEWALGREENS CO.ANDACurrent
11673-111DYE-FREE CHILDRENS LORATADINELORATADINEUP & UPANDACurrent
11673-115Dye-Free Childrens LoratadineLORATADINEUP & UPANDACurrent
11673-996Childrens AllergyLORATADINETARGET CORPORATIONANDACurrent
11673-996Childrens AllergyLORATADINETARGET CORPORATIONANDACurrent
11673-997CHILDRENS LORATADINELORATADINETARGET CORPORATIONANDACurrent
11673-997CHILDRENS LORATADINELORATADINETARGET CORPORATIONANDACurrent
11822-7240LORATADINELORATADINERite AidANDACurrent
11822-8329DYE-FREE CHILDRENS LORATADINELORATADINERITE AIDANDACurrent
11822-9999Dye-Free Childrens LoratadineLoratadineRITE AIDANDACurrent
21130-646DYE-FREE CHILDRENS LORATADINELORATADINESAFEWAYANDACurrent
21130-999CHILDRENS LORATADINELORATADINESAFEWAYANDACurrent
21130-999CHILDRENS LORATADINELORATADINESAFEWAYANDACurrent
30142-984LoratadineLoratadineKROGER COMPANYANDACurrent
30142-996LoratadineLoratadineKROGER COMPANYANDACurrent
46122-550Childrens LoratadineLORATADINEAmerisource BergenANDACurrent
49035-953LoratadineLoratadineWal-Mart Stores, IncANDACurrent
49035-953LoratadineLoratadineWal-Mart Stores, IncANDACurrent
51660-106DYE-FREE CHILDRENS LORATADINELORATADINEOhm Laboratories Inc.ANDACurrent
51660-112Dye-Free Childrens LoratadineLORATADINEOhm Laboratories Inc.ANDACurrent
51660-753LoratadineLoratadineOhm Laboratories Inc.ANDACurrent
51660-753LoratadineLoratadineOhm Laboratories Inc.ANDACurrent
51660-754Childrens LoratadineLORATADINEOhm Laboratories Inc.ANDACurrent
51660-754Childrens LoratadineLORATADINEOhm Laboratories Inc.ANDACurrent
56062-900DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INCANDACurrent
56062-990LORATADINELORATADINEPUBLIX SUPER MARKETS INCANDACurrent
56062-990LORATADINELORATADINEPUBLIX SUPER MARKETS INCANDACurrent
68016-053LoratadineLoratadinePremier ValueANDACurrent
69842-894Dye-Free Childrens LoratadineLoratadineCVS PHARMACY, INCANDACurrent
69842-895Dye-Free Childrens LoratadineLoratadineCVS PHARMACY, INCANDACurrent
69842-895Dye-Free Childrens LoratadineLoratadineCVS PHARMACY, INCANDACurrent
69842-953CHILDRENS LORATADINELORATADINECVS PHARMACY, INCANDACurrent
69842-954CHILDRENS LORATADINELORATADINECVS PHARMACY, INCANDACurrent
79903-008DYE-FREE CHILDRENS LORATADINELORATADINEWAL-MART STORES, INCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54168ORIG2018-05-11