FDA.reportPublic FDA data

Application 210722

Type
ANDA
Sponsor
GRANULES INDIA 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
29485-551524 / 7 Life Non-Drowsy Allergy Reliefloratadine tabletMechanical Servants, LLCANDACurrent
29485-815624 / 7 Life Non-Drowsy Allergy Reliefloratadine tabletMechanical Servants, LLCANDACurrent
42961-120First Aid Direct Allergy ReliefLoratadine TabletsCintas CorporationANDACurrent
51824-075CAREALL LoratadineLoratadineNew World ImportsANDACurrent
51824-075CAREALL LoratadineLoratadineNew World ImportsANDACurrent
53117-414Allergy ReliefLoratadine 10mgFirst Aid DirectANDACurrent
53117-414Allergy ReliefLoratadine 10mgFirst Aid DirectANDACurrent
53943-193Allergy ReliefLoratadineDISCOUNT DRUG MARTANDACurrent
55681-303ALLERGY RELIEFLORATADINETWIN MED LLCANDACurrent
55681-303ALLERGY RELIEFLORATADINETWIN MED LLCANDACurrent
57344-193Allergy ReliefLoratadineAAA PHARMACEUTICAL, INC.ANDACurrent
57344-193Allergy ReliefLoratadineAAA PHARMACEUTICAL, INC.ANDACurrent
62207-787LoratadineLoratadineGranules India LtdANDACurrent
62207-787LoratadineLoratadineGranules India LimitedANDACurrent
62207-787LoratadineLoratadineGranules India LimitedANDACurrent
63941-193Allergy ReliefLoratadineValu Merchandisers CompanyANDACurrent
68210-4110LoratadineLoratadineSpirit Pharmaceuticals LLCANDACurrent
68210-4110LoratadineLoratadineSpirit Pharmaceuticals LLCANDACurrent
68998-414Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-414Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-414Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-414Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
69168-414Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-414Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-414Allergy ReliefLoratadineAllegiant HealthANDACurrent
69230-328LORATADINELORATADINECamber Consumer Care IncANDACurrent
69848-019LoratadineLoratadineGRANULES USA, INC.ANDACurrent
70010-162LoratadineLoratadineGranules Pharmaceuticals Inc.ANDACurrent
70010-162LoratadineLoratadineGranules Pharmaceuticals Inc.ANDACurrent
70010-162LoratadineLoratadineGranules Pharmaceuticals Inc.ANDACurrent
71309-007LoratadineLoratadineSafrel Pharmaceuticals, LLCANDACurrent
72036-193Allergy ReliefLoratadineHARRIS TEETERANDACurrent
72036-193Allergy ReliefLoratadineHARRIS TEETERANDACurrent
73581-230LORATADINE ALLERGY RELIEFLORATADINEYYBA CORPANDACurrent
73629-003LORATADINELORATADINEAMZ789 LLCANDACurrent
81522-393Allergy ReliefLoratadineFSA STORE INC.ANDACurrent