FDA.reportPublic FDA data

Application 078512

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
0904-7187AtenololAtenololMajor PharmaceuticalsANDACurrent
13107-168AtenololAtenololAurolife Pharma LLCANDACurrent
13107-169AtenololAtenololAurolife Pharma LLCANDACurrent
13107-170AtenololAtenololAurolife Pharma LLCANDACurrent
50090-5738AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5741AtenololAtenololA-S Medication SolutionsANDACurrent
51138-096AtenololAtenololMed-Health Pharma, LLCANDACurrent
51138-097AtenololAtenololMed-Health Pharma, LLCANDACurrent
51138-098AtenololAtenololMed-Health Pharma, LLCANDACurrent
53808-0658AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0660AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
53808-0900AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
65862-168AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-168AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-168AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-168AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-168AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-169AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-169AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-169AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-169AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-169AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-170AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-170AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-170AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-170AtenololAtenololAurobindo Pharma LimitedANDACurrent
65862-170AtenololAtenololAurobindo Pharma LimitedANDACurrent
68788-7876AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7876AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7876AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
70518-3036AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3036AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3036AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3036AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3531AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3531AtenololAtenololREMEDYREPACK INC.ANDACurrent