FDA.reportPublic FDA data

Application 091624

Type
ANDA
Sponsor
LANNETT CO 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
43063-487Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-487Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-487Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-487Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-487Atorvastatin CalciumAtorvastatin CalciumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-280Atorvastatin CalciumAtorvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-983Atorvastatin CalciumAtorvastatin CalciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-726Atorvastatin CalciumAtorvastatin Calciummedsource pharmaceuticalsANDACurrent
45865-743Atorvastatin CalciumAtorvastatin Calciummedsource pharmaceuticalsANDACurrent
50090-1255Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-1255Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-1258Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-1258Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-1261Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-1265Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5069Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
50090-5069Atorvastatin CalciumAtorvastatin CalciumA-S Medication SolutionsANDACurrent
51655-614Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
51655-650atorvastatin calciumatorvastatin calciumNorthwind Pharmaceuticals, LLCANDACurrent
51655-921Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
53002-1335Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1335Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1439Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1439Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1440Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1440Atorvastatin CalciumAtorvastatin CalciumRPK Pharmaceuticals, Inc.ANDACurrent
53217-209Atorvastatin CalciumAtorvastatin CalciumAidarex Pharmaceuticals LLCANDACurrent
55700-659Atorvastatin CalciumAtorvastatin CalciumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-659Atorvastatin CalciumAtorvastatin CalciumLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-903Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-903Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-904Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-905Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-905Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-905Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-905Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
60760-905Atorvastatin CalciumAtorvastatin CalciumSt. Mary's Medical Park PharmacyANDACurrent
61919-632ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
61919-632ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
61919-632ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
61919-956ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXANDACurrent
61919-956Atorvastatin CalciumAtorvastatin CalciumDirect_RxANDACurrent
61919-956Atorvastatin CalciumAtorvastatin CalciumDirect_RxANDACurrent
61919-956Atorvastatin CalciumAtorvastatin CalciumDirect_RxANDACurrent
61919-956Atorvastatin CalciumAtorvastatin CalciumDirect_RxANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc..ANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-890Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc..ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-891Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc..ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-892Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc..ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
62175-897Atorvastatin CalciumAtorvastatin CalciumLannett Company, Inc.ANDACurrent
63187-336Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63187-336Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63187-336Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63187-346Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63187-346Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63187-346Atorvastatin CalciumAtorvastatin CalciumProficient Rx LPANDACurrent
63629-8031Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-8031Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-8033Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
63629-8033Atorvastatin CalciumAtorvastatin CalciumBryant Ranch PrepackANDACurrent
67296-1620Atorvastatin CalciumAtorvastatin CalciumRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43254ORIG2015-03-09