FDA.reportPublic FDA data

Application 205300

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5056Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5057Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5058Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA,ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5059Atorvastatin CalciumAtorvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-003Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-004Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
42708-005Atorvastatin CalciumAtorvastatin CalciumQPharma IncANDACurrent
45865-727Atorvastatin CalciumAtorvastatin Calciummedsource pharmaceuticalsANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-0087Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
68071-3371Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3374Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4185Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4472Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4506Atorvastatin CalciumAtorvastatin CalciumNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0813Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-0813Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
71205-098Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
71205-098Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47762ORIG2017-03-29