FDA.reportPublic FDA data

Application 078034

Type
ANDA
Sponsor
BIOCON LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET;ORAL5MGNoNo
002SIMVASTATINSIMVASTATINTABLET;ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET;ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET;ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-500SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-500SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-501SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-501SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-502SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-502SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-502SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-503SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-503SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-503SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-504SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-504SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
24658-504SimvastatinSimvastatinPuraCap Laboratories, LLCANDACurrent
43353-768SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-773SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
53808-0927SimvastatinSimvastatinState of Florida DOH Central PharmacyANDACurrent
53808-0952SimvastatinSimvastatinState of Florida DOH Central PharmacyANDACurrent
53808-1078SimvastatinSimvastatinState of Florida DOH Central PharmacyANDACurrent
55154-9525SimvastatinSimvastatinCardinal HealthANDACurrent
63629-1196SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1196SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1196SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1197SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1197SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1197SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1198SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1198SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1198SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1199SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1199SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1199SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1200SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1200SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
63629-1200SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
65727-065SimvastatinSimvastatinBiocon LimitedANDACurrent
65727-066SimvastatinSimvastatinBiocon LimitedANDACurrent
65727-067SimvastatinSimvastatinBiocon LimitedANDACurrent
65727-068SimvastatinSimvastatinBiocon LimitedANDACurrent
65727-069SimvastatinSimvastatinBiocon LimitedANDACurrent
70377-001SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-001SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-001SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-001SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-001SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-002SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-002SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-002SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-002SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-002SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-003SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-003SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-003SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-003SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-003SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-004SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-004SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-004SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-004SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-004SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-005SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-005SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-005SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-005SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
70377-005SimvastatinSimvastatinBiocon Pharma Inc,ANDACurrent
71335-1891SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1891SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1905SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1905SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1906SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-1906SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71335-2147SimvastatinSimvastatinBryant Ranch PrepackANDACurrent
71610-609SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-610SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-611SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-615SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-622SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-623SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44371ORIG2011-05-26