FDA.reportPublic FDA data

Application 076134

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8317LoratadineLoratadineKaiser Foundation HospitalsANDACurrent
0363-0522LoratadineLoratadineWalgreen CompanyANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
0904-6074LoratadineLoratadineMajor PharmaceuticalsANDACurrent
10135-763Loratadine Allergy ReliefLoratadineMarlex Pharmaceuticals, Inc.ANDACurrent
15127-715LoratadineLoratadineSelect BrandANDACurrent
21130-526LoratadineLoratadineSAFEWAY INC.ANDACurrent
21130-526LoratadineLoratadineSAFEWAY INC.ANDACurrent
37012-526LoratadineLoratadineShopko Stores Operating Co., LLCANDACurrent
37205-346LEADER LoratadineloratadineCardinal HealthANDACurrent
37808-529Loratadine Allergy ReliefLoratadineHEBANDACurrent
41163-526LoratadineLoratadineSUPERVALU INC.ANDACurrent
46122-158LoratadineLoratadineAmerisource BergenANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-203MEDIQUE LoradamedLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
47682-913Medi First Plus Allergy ReliefLoratadineUnifirst First Aid CorporationANDACurrent
49614-170Medicine Shoppe Loratadine Allergy ReliefLoratadineThe Medicine Shoppe InternationalANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
50090-2387Loratadine Allergy ReliefLoratadineA-S Medication SolutionsANDACurrent
51655-027LoratadineLoratadineNorthwind Pharmaceuticals, LLCANDACurrent
51660-209LoratadineLoratadineOhm Laboratories Inc.ANDACurrent
51660-526Loratadine Allergy ReliefLoratadineOHM LABORATORIES INC.ANDACurrent
51660-526Loratadine Allergy ReliefLoratadineOHM LABORATORIES INC.ANDACurrent
53002-7490Loratadine Allergy ReliefLoratadineRPK Pharmaceuticals, Inc.ANDACurrent
53002-7490Loratadine Allergy ReliefLoratadineRPK Pharmaceuticals, Inc.ANDACurrent
53329-651LoratadineLoratadineMedline Industries, Inc.ANDACurrent
53943-975Loratadine Allergy ReliefLoratadineDISCOUNT DRUG MARTANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-728Loratadine Allergy ReliefLoratadinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55315-528LoratadineLoratadineFred's Inc.ANDACurrent
55315-528LoratadineLoratadineFred's Inc.ANDACurrent
55319-526LoratadineLoratadineFamily Dollar Services, Inc.ANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55670-478Moore Medical LoratadineLoratadineMoore Medical LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-097Loratadine Allergy ReliefLoratadineLake Erie Medical DBA Quality Care Products LLCANDACurrent
56062-526LoratadineLoratadinePublix Super Markets IncANDACurrent
56062-526LoratadineLoratadinePublix Super Markets IncANDACurrent
59564-251LoratadineLoratadineInnovative Manufacturing and Distribution Services, Inc.ANDACurrent
59779-528LoratadineLoratadineCVS PharmacyANDACurrent
59779-528LoratadineLoratadineCVS PharmacyANDACurrent
61715-017LoratadineLoratadineKinrayANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63187-100Loratadine Allergy ReliefLoratadineProficient Rx LPANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63629-7772Loratadine Allergy ReliefLoratadineBryant Ranch PrepackANDACurrent
63868-151LoratadineLoratadineChain Drug Marketing Association Inc.ANDACurrent
63941-526LoratadineLoratadineValu Merchandisers CompanyANDACurrent
64725-0526Loratadine Allergy ReliefLoratadineTYA PharmaceuticalsANDACurrent
67046-452Loratadine Allergy ReliefLoratadineContract Pharmacy Services-PAANDACurrent
67091-245Loratadine Allergy ReliefLoratadineWinCo Foods, LLCANDACurrent
67091-246Loratadine Allergy ReliefLoratadineWinCo Foods, LLCANDACurrent
67751-163Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.ANDACurrent
67751-163Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.ANDACurrent
68016-526LoratadineLoratadinePremier ValueANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43056ORIG2012-03-28
31084ORIG2003-04-16