FDA.reportPublic FDA data

Application 076900

Type
ANDA
Sponsor
ZYDUS PHARMS USA

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
10544-031AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-126AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
12634-605AtenololAtenololApotheca Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-952AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0442AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0442AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0448AtenololAtenololA-S Medication SolutionsANDACurrent
50090-0514AtenololAtenololA-S Medication SolutionsANDACurrent
53217-181AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53217-365AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53808-0207AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0344AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0730AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA QuaANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-531AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA QuaANDACurrent
55700-566AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-567AtenololAtenololLake Erie Medical DBA Quality Care Procucts LLCANDACurrent
55700-567AtenololAtenololLake Erie Medical DBA QuaANDACurrent
58118-2022AtenololAtenololClinical Solutions WholesANDACurrent
60687-605AtenololAtenololAmerican Health PackagingANDACurrent
60687-605AtenololAtenololAmerican Health PackagingANDACurrent
60760-163AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-164AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
61919-581ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-581ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-935ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-935ATENOLOLATENOLOLDirect_RxANDACurrent
61919-935ATENOLOLATENOLOLDirect_RxANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-022AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-022AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-023AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-023AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
65841-024AtenololAtenololZydus Lifesciences LimitedANDACurrent
65841-024AtenololAtenololCadila Healthcare LimitedANDACurrent
66267-029AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-029AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-031AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-031AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1558AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1589AtenololAtenololRedPharm Drug, Inc.ANDACurrent
68071-2248AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2248AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3190AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3190AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68151-2471AtenololAtenololCarilion Materials ManagementANDACurrent
68151-2889AtenololAtenololCarilion Materials ManagementANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-022AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-023AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-024AtenololAtenololZydus Pharmaceuticals USA Inc.ANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-493AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6458AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-6458AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-6969AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent