FDA.reportPublic FDA data

Application 077662

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8019GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8098GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8098GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8132GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8132GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8233GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8233GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-439GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
10544-448GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
42254-054GabapentinGabapentinRebel Distributors CorpANDACurrent
42254-109GabapentinGabapentinRebel Distributors CorpANDACurrent
45865-356GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-356GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-405GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
49999-784GabapentinGabapentinLake Erie Medica & Surgical Supply DBA Quality Care Products LLCANDACurrent
49999-799GabapentinGabapentinLake Erie Medical & Surgical S6758upply DBA Quality Care Products LLCANDACurrent
49999-799GabapentinGabapentinQuality Care Products, LLCANDACurrent
50436-0126GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-7210GabapentinGabapentinUnit Dose ServicesANDACurrent
52959-772GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
52959-789GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
53217-282GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-959GabapentinGabapentinPD-Rx Pharmaceuticals, Inc.ANDACurrent
60760-123GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-123GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-173GabapentinGabapentinSt. MaryANDACurrent
60760-173GabapentinGabapentinSt. MaryANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-350GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-350GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-677GABAPENTINGABAPENTINDIRECTRXANDACurrent
63187-010GabapentinGabapentinProficient Rx LPANDACurrent
63187-010GabapentinGabapentinProficient Rx LPANDACurrent
63187-057GabapentinGabapentinProficient Rx LPANDACurrent
63187-057GabapentinGabapentinProficient Rx LPANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3063GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7307GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7307GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7308GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7308GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7666GabapentinGabapentinBryant Ranch PrepackANDACurrent
64725-0126GabapentinGabapentinTYA PharmaceuticalsANDACurrent
67046-227GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67046-229GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-411GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68001-412GabapentinGabapentinBluePoint LaboratoriesANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1292GabapentinGabapentinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4087GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4180GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-126GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-127GabapentinGabapentinGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-9023GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent