FDA.reportPublic FDA data

Application 203244

Type
ANDA
Sponsor
ACI HEALTHCARE LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-332GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-332GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-333GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-333GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
45865-122GabapentinGABAPENTINMedsource PharmaceuticalsANDACurrent
45865-995GabapentinGABAPENTINmedsource pharmaceuticalsANDACurrent
55700-278GabapentinGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-389GabapentinGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
60760-066GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-066GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-067GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
61919-387GABAPENTINGABAPENTINDIRECT RXANDACurrent
63629-8061GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
63629-8061GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
67046-341GabapentinGABAPENTINContract Pharmacy Services-PAANDACurrent
67046-413GabapentinGABAPENTINContract Pharmacy Services-PAANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,InANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7098GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7098GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7288GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7288GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70934-593GabapentinGABAPENTINDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-593GabapentinGABAPENTINDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-457GabapentinGABAPENTINProficient Rx LPANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent