FDA.reportPublic FDA data

Application 207687

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASENoNo
003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASENoNo
004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-044ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-045ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-046ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
16729-047ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.ANDACurrent
50090-5497ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
50090-5921ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
50090-5921ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
50090-6057ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication SolutionsANDACurrent
51655-946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind PharmaceuticalsANDACurrent
53002-2335ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRPK Pharmaceuticals, Inc.ANDACurrent
53002-2439ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRPK Pharmaceuticals, Inc.ANDACurrent
53002-2440ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRPK Pharmaceuticals, Inc.ANDACurrent
55700-871ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQuality Care Products, LLCANDACurrent
55700-871ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQuality Care Products, LLCANDACurrent
55700-877ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQuality Care Products, LLCANDACurrent
55700-877ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQuality Care Products, LLCANDACurrent
68071-2389ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2441ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2468ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2680ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5168ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5168ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5194ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5194ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5198ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5198ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7630ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7630ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7630ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7631ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7631ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7631ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7799ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7799ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
68788-7799ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1946ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70518-1977ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.ANDACurrent
70934-360ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-360ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-360ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-360ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-246ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
71205-246ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
71205-246ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
71205-246ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
71205-247ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent