FDA.reportPublic FDA data

Application 076477

Type
ANDA
Sponsor
SUN PHARM INDS LTD

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
33261-972Atorvastatin CalciumAtorvastatin CalciumAidarex Pharmaceuticals LLCANDACurrent
43063-373Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-373Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-373Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-373Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-843Atorvastatin CalciumAtorvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3536Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5298Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5298Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
51655-610Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
51655-640Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
51655-920Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
60760-829Atorvastatin CalciumAtorvastatin CalciumST. MARY'S MEDICAL PARK PHARMACYANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-827Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-828Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-829Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63304-830Atorvastatin CalciumAtorvastatin CalciumSun Pharmaceutical Industries Inc.ANDACurrent
63629-4850Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-4850Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
67296-1422Atorvastatin CalciumAtorvastatin CalciumRedPharm Drug, Inc.ANDACurrent
68071-2276Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2276Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2687Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2755Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2871Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2872Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4480Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68258-6041Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68258-6042Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68258-6043Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68258-6044Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68258-6992Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68258-6993Atorvastatin CalciumAtorvastatin CalciumDispensing Solutions, Inc.ANDACurrent
68788-8315Atorvastatin CalciumAtorvastatin CalciumPreferred Pharmaceutical Inc.ANDACurrent
70518-2664Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2664Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-2664Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-3461Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70934-296Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-296Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-296Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-296Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-296Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-312Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-312Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-312Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-312Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-312Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-342Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-342Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-342Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-342Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-513Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-264Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
71205-264Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
71205-264Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43080ORIG2014-07-07
31127ORIG2011-12-01