FDA.reportPublic FDA data

Application 091650

Type
ANDA
Sponsor
DR REDDYS LABS 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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7769Atorvastatin CalciumAtorvastatin CalciumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7770Atorvastatin CalciumAtorvastatin CalciumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7771Atorvastatin CalciumAtorvastatin CalciumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
35356-860Atorvastatin CalciumAtorvastatin CalciumLake Erie Medical DBA Quality Care Products LLCANDACurrent
53808-1008Atorvastatin CalciumAtorvastatin CalciumState of Florida DOH Central PharmacyANDACurrent
53808-1067Atorvastatin CalciumAtorvastatin CalciumState of Florida DOH Central PharmacyANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-121Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-122Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55111-123Atorvastatin CalciumAtorvastatin CalciumDr. Reddy's Laboratories LimitedANDACurrent
55700-548Atorvastatin CalciumAtorvastatin CalciumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-548Atorvastatin CalciumAtorvastatin CalciumLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-258ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirect_RxANDACurrent
61919-258ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirect_RxANDACurrent
61919-258ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirect_RxANDACurrent
61919-543ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirectRXANDACurrent
61919-916ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirectRXANDACurrent
63739-018Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-018Atorvastatin CalciumAtorvastatin CalciumMcKesson Corporation dba SKY PackagingANDACurrent
63739-018Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-020Atorvastatin CalciumAtorvastatin CalciumMcKesson Corporation dba SKY PackagingANDACurrent
63739-020Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-020Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-036Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-036Atorvastatin CalciumAtorvastatin CalciumMcKesson Corporation dba SKY PackagingANDACurrent
63739-036Atorvastatin CalciumAtorvastatin CalciumMckesson Corporation DBA SKY PackaginngANDACurrent
67296-1143Atorvastatin CalciumAtorvastatin CalciumRedPharm Drug, Inc.ANDACurrent
67296-1143Atorvastatin CalciumAtorvastatin CalciumRedPharm Drug, Inc.ANDACurrent
67296-1143Atorvastatin CalciumAtorvastatin CalciumRedPharm Drug, Inc.ANDACurrent
68788-6331Atorvastatin CalciumAtorvastatin CalciumPreferred Pharmaceuticals Inc.ANDACurrent
70518-0383Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1589Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70518-1589Atorvastatin CalciumAtorvastatin CalciumREMEDYREPACK INC.ANDACurrent
70934-201Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-201Atorvastatin CalciumAtorvastatin CalciumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76519-1075Atorvastatin CalciumAtorvastatin CalciumH.J. Harkins Company Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65846ORIG2021-01-07