FDA.reportPublic FDA data

Application 090548

Type
ANDA
Sponsor
APOTEX INC

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
0440-7128ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLiberty Pharmaceuticals, Inc.ANDACurrent
0615-8006ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8006ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, IncANDACurrent
0615-8006ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8007ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8007ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8007ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8007ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8008ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8008ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8009ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8009ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8009ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8009ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6290ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6290ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6290ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6290ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6290ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6291ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6291ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6291ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6291ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6291ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6292ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6292ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6292ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6292ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6292ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6293ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6293ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6293ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6293ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
0904-6293ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor PharmaceuticalsANDACurrent
10544-874ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBlenheim Pharmacal, Inc.ANDACurrent
16714-173ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-173ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-173ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-174ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-174ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-174ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-175ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-175ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-175ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-176ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-176ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
16714-176ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLCANDACurrent
33261-959ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAidarex Pharmaceuticals LLCANDACurrent
35356-894ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-929ATORVASTATIN CALCIUMATORVASTATIN CALCIUMLake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-013ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-013ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-013Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-014Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-014ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-014ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-108ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-108ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
42708-108ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma IncANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-474ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-496ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-496ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-496ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-496ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22711ORIG2015-03-09