Application 207068

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL10MGNoNo
002PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL20MGNoNo
003PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL40MGNoNo
004PRAVASTATIN SODIUMPRAVASTATIN SODIUMTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-008PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-009PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-009PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-009PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-009PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-009PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-010PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-010PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-010PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-010PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-010PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-011PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-011PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-011PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-011PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
16729-011PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.ANDACurrent
43063-807PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-807PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-807PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-807PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, InANDACurrent
43063-807PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-808PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-808PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-808PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-808PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-808PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3258PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
50090-3258PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
50090-3898PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
50090-3898PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
50090-3898PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
50090-6145PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication SolutionsANDACurrent
60760-421PRAVASTATIN SODIUMPRAVASTATIN SODIUMSt. Mary's Medical Park PharmacyANDACurrent
60760-421PRAVASTATIN SODIUMPRAVASTATIN SODIUMSt. Mary's Medical Park PharmacyANDACurrent
60760-422PRAVASTATIN SODIUMPRAVASTATIN SODIUMSt. Mary's Medical Park PharmacyANDACurrent
61919-707PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
61919-707PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
61919-708Pravastatin SodiumPravastatin SodiumDirect_RxANDACurrent
61919-708Pravastatin SodiumPravastatin SodiumDirect_RxANDACurrent
61919-709PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RXANDACurrent
61919-734Pravastatin SodiumPravastatin SodiumDirect_RxANDACurrent
68071-3247PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3247PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3358PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3358PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3358PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4039PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4039PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7013PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7013PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7253PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7253PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7316PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7316PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7413PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7413PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.ANDACurrent
70518-0412PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-0412PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1157PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1197PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1197PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1710PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1710PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1902PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-1902PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.ANDACurrent
70934-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-161PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-236PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-236PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-358PRAVASTATIN SODIUMPRAVASTATIN SODIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent