FDA.reportPublic FDA data

Application 076557

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL10MG;240MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0725Loratadine and PseudoephedrineLoratadine and PseudoephedrineWalgreen CompanyANDACurrent
0363-0725Loratadine and PseudoephedrineLoratadine and PseudoephedrineWalgreen CompanyANDACurrent
0904-5833Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateMajor PharmaceuticalsANDACurrent
0904-5833Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateMajor PharmaceuticalsANDACurrent
11673-165Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateTarget CorporationANDACurrent
11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATERite AidANDACurrent
11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATERite AidANDACurrent
11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATERite AidANDACurrent
11822-9990Loratadine and PseudoephedrineLORATADINE and PSEUDOEPHEDRINE SULFATERite AidANDACurrent
15127-717Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateSelect BrandANDACurrent
21130-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateSafeway Inc.ANDACurrent
21130-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateSafeway Inc.ANDACurrent
21695-729Loratadine and Pseudoephedrineloratadine and pseudoephedrineRebel Distributors CorpANDACurrent
30142-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateThe Kroger CompanyANDACurrent
30142-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateThe Kroger CompanyANDACurrent
36800-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateTopco Associates LLCANDACurrent
37012-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateShopko Stores Operating Co., LLCANDACurrent
37205-348Leader Allergy Relief D-24Loratadine and Pseudoephedrine SulfateCardinal HealthANDACurrent
37808-427Loratadine and Pseudoephedrine Sulfateloratadine and pseudoephedrine sulfateHEBANDACurrent
37808-724Loratadine and Pseudoephedrine Sulfateloratadine and pseudoephedrine sulfateHEBANDACurrent
41163-165Loratadine and PseudoephedrineLoratadine and PseudoephedrineSUPERVALU INC.ANDACurrent
41250-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateMeijer Distribution, Inc.ANDACurrent
41250-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateMeijer Distribution, Inc.ANDACurrent
46122-167Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateAmerisource BergenANDACurrent
46122-167Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateAmerisource BergenANDACurrent
46122-167Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateAmerisource BergenANDACurrent
46122-383Loratadine and Pseudoephedrineloratadine and pseudoephedrineAMERISOURCE BERGENANDACurrent
46122-383Loratadine and Pseudoephedrineloratadine and pseudoephedrineAMERISOURCE BERGENANDACurrent
49035-488Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateWAL-MART STORES, INCANDACurrent
49348-543Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateSTRATEGIC SOURCING SERVICESANDACurrent
49348-543Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateSunmarkANDACurrent
49614-172Medicine Shoppe Allergy Relief D24Loratadine and Pseudoephedrine SulfateThe Medicine Shoppe InternationalANDACurrent
51660-488Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
51660-491Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
51660-491Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
51660-724Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
51660-724Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
51660-724Loratadine and Pseudoephedrineloratadine and pseudoephedrineOhm Laboratories Inc.ANDACurrent
56062-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfatePublix Super Markets IncANDACurrent
59779-726ALLERGY RELIEF-DLoratadine and PseudoephedrineCVS PharmacyANDACurrent
59779-726ALLERGY RELIEF-DLoratadine and PseudoephedrineCVS PharmacyANDACurrent
61715-016Loratadine and PseudoephedrineLoratadine and PseudoephedrineKinrayANDACurrent
62011-0071Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateHealth MartANDACurrent
62011-0071Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateHealth MartANDACurrent
62011-0071Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateStrategic Sourcing Services LLCANDACurrent
62011-0071Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateStrategic Sourcing Services LLCANDACurrent
63187-305Loratadine and Pseudoephedrineloratadine and pseudoephedrineProficient Rx LPANDACurrent
63187-305Loratadine and Pseudoephedrineloratadine and pseudoephedrineProficient Rx LPANDACurrent
63629-7766Loratadine and Pseudoephedrineloratadine and pseudoephedrineBryant Ranch PrepackANDACurrent
63629-7766Loratadine and Pseudoephedrineloratadine and pseudoephedrineBryant Ranch PrepackANDACurrent
63629-7766Loratadine and Pseudoephedrineloratadine and pseudoephedrineBryant Ranch PrepackANDACurrent
63868-154Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateChain Drug Marketing Association Inc.ANDACurrent
63981-724KIRKLAND SIGNATURE ALLERCLEAR D 24 HRloratadine and pseudoephedrine sulfateKirkland-COSTCO WHOLESALE COMPANYANDACurrent
63981-724KIRKLAND SIGNATURE ALLERCLEAR D 12 HRloratadine and pseudoephedrine sulfateKirkland-COSTCO WHOLESALE COMPANYANDACurrent
68016-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateChain Drug Consortium, LLCANDACurrent
68016-724Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateChain Drug Consortium, LLCANDACurrent
70000-0162Leader Allergy Relief D-24Loratadine and Pseudoephedrine SulfateCardinal HealthANDACurrent
70000-0162Leader Allergy Relief D-24Loratadine and Pseudoephedrine SulfateCardinal HealthANDACurrent
70000-0162Leader Allergy Relief D-24Loratadine and Pseudoephedrine SulfateCardinal HealthANDACurrent
70000-0162Leader Allergy Relief D-24Loratadine and Pseudoephedrine SulfateCardinal HealthANDACurrent
70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateREMEDYREPACK INC.ANDACurrent
70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateREMEDYREPACK INC.ANDACurrent
70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateREMEDYREPACK INC.ANDACurrent
70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateREMEDYREPACK INC.ANDACurrent
70518-0371Loratadine and Pseudoephedrine SulfateLoratadine and Pseudoephedrine SulfateREMEDYREPACK INC.ANDACurrent
70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrineREMEDYREPACK INC.ANDACurrent
70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrineREMEDYREPACK INC.ANDACurrent
70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrineREMEDYREPACK INC.ANDACurrent
70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrineREMEDYREPACK INC.ANDACurrent
70518-0653Loratadine and Pseudoephedrineloratadine and pseudoephedrineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22570ORIG2011-02-15