FDA.reportPublic FDA data

Application 077877

Type
ANDA
Sponsor
IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL25MGNoNo
002ATENOLOLATENOLOLTABLET;ORAL50MGNoNo
003ATENOLOLATENOLOLTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-127AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-134AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-171AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
12634-436AtenololAtenololApotheca Inc.ANDACurrent
21695-322AtenololAtenololRebel Distributors Corp.ANDACurrent
33261-220AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
33261-349AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
33261-517AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
42254-046AtenololAtenololRebel Distributors CorpANDACurrent
42254-107AtenololAtenololRebel Distributors CorpANDACurrent
51655-926AtenololAtenololNorthwind Pharmaceuticals, LLCANDACurrent
51655-927ATENOLOLATENOLOLNorthwind Pharmaceuticals, LLCANDACurrent
52959-463AtenololAtenololH.J. Harkins Company, Inc.ANDACurrent
53808-0345AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0346AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
55289-227AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-228AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
60760-059AtenololAtenololSt Marys Medical Park PharmacyANDACurrent
61919-257ATENOLOLATENOLOLDirect RxANDACurrent
61919-257ATENOLOLATENOLOLDirect RxANDACurrent
61919-914ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-914ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-914ATENOLOLATENOLOLDIRECT RXANDACurrent
63187-092AtenololAtenololProficient Rx LPANDACurrent
63187-092AtenololAtenololProficient Rx LPANDACurrent
63304-621AtenololAtenololRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-622AtenololAtenololRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-623AtenololAtenololRanbaxy Pharmaceuticals Inc.ANDACurrent
63629-1785AtenololAtenololBryant Ranch PrepackANDACurrent
63629-1785AtenololAtenololBryant Ranch PrepackANDACurrent
63629-2626AtenololAtenololBryant Ranch PrepackANDACurrent
63629-2626AtenololAtenololBryant Ranch PrepackANDACurrent
64725-0621AtenololAtenololTYA PharmaceuticalsANDACurrent
66116-389AtenololAtenololMedVantx, Inc.ANDACurrent
67046-031AtenololatenololContract Pharmacy Services-PAANDACurrent
67296-0671AtenololAtenololRedPharm Drug Inc.ANDACurrent
67296-0674AtenololAtenololRedPharm Drug Inc.ANDACurrent
67296-0676AtenololAtenololRedPharm Drug Inc.ANDACurrent
67296-0755AtenololAtenololRedPharm Drug Inc.ANDACurrent
68788-9047AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9048AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9049AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent