FDA.report

Application 075350

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1376GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1377GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1378GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7762GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7839GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7844GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7845GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42495-556GabapentinGabapentinWestwood ManufacturingANDACurrent
43353-075GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-081GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-555GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-556GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
45963-557GabapentinGabapentinActavis Pharma, Inc.ANDACurrent
50090-2561GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-3318GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-5550GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-5550GabapentinGabapentinUnit Dose ServicesANDACurrent
53002-3423GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
53002-4423GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
55154-4691GabapentinGabapentinCardinal HealthANDACurrent
55154-4691GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7129GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55154-7131GabapentinGabapentinCardinal HealthANDACurrent
55695-017GabapentinGabapentinDepartment of State Health Services, Pharmacy BranchANDACurrent
59088-725Gaba 300-EZSGabapentinPureTek CorporationANDACurrent
60760-557GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
61786-469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
61919-083GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-083GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-252GABAPENTINGABAPENTINDirectRXANDACurrent
61919-252GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-252GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-839GABAPENTINGABAPENTINDIRECT RXANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63187-988GabapentinGabapentinProficient Rx LPANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6792GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7305GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7309GabapentinGabapentinBryant Ranch PrepackANDACurrent
64725-0511GabapentinGabapentinTYA PharmaceuticalsANDACurrent
66116-358GabapentinGabapentinMedVantx, Inc.ANDACurrent
67046-703GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67544-353GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-354GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-361GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-1995GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3046GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent

Documents

DocumentSubmission typeDate
24152ORIG2008-02-01
22462ORIG2007-07-06