FDA.reportPublic FDA data

Application 077241

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL20MGNoNo
002BACLOFENBACLOFENTABLET;ORAL10MGNoNo
003BACLOFENBACLOFENTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1333BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0527-1337BaclofenbaclofenLannett Company, Inc.ANDACurrent
0904-6476BaclofenbaclofenMajor PharmaceuticalsANDACurrent
0904-6476BaclofenbaclofenMajor PharmaceuticalsANDACurrent
0904-6476BaclofenbaclofenMajor PharmaceuticalsANDACurrent
0904-6476BaclofenbaclofenMajor PharmaceuticalsANDACurrent
0904-6476BaclofenbaclofenMajor PharmaceuticalsANDACurrent
10135-532BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-532BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-533BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-533BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-533BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-533BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
10135-533BaclofenbaclofenMarlex Pharmaceuticals IncANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-865BaclofenbaclofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-355BaclofenbaclofenMedsource PharmaceuticalsANDACurrent
50090-2871BaclofenbaclofenA-S Medication SolutionsANDACurrent
50090-2871BaclofenbaclofenA-S Medication SolutionsANDACurrent
55154-7876BaclofenbaclofenCardinal Health, Inc.ANDACurrent
55154-7876BaclofenbaclofenCardinal Health, Inc.ANDACurrent
55154-7876BaclofenbaclofenCardinal Health 107, LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-408BaclofenbaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-095BACLOFENBACLOFENDIRECT RXANDACurrent
61919-095BACLOFENBACLOFENDirect_RxANDACurrent
61919-095BACLOFENBACLOFENDirect_RxANDACurrent
61919-095BACLOFENBACLOFENDirect_RxANDACurrent
61919-095BACLOFENBACLOFENDIRECT RXANDACurrent
63187-280BaclofenbaclofenProficient Rx LPANDACurrent
63187-280BaclofenbaclofenProficient Rx LPANDACurrent
63187-313BaclofenbaclofenProficient Rx LPANDACurrent
63187-313BaclofenbaclofenProficient Rx LPANDACurrent
63629-2083BaclofenbaclofenBryant Ranch PrepackANDACurrent
63629-2083BaclofenbaclofenBryant Ranch PrepackANDACurrent
63629-2084BaclofenbaclofenBryant Ranch PrepackANDACurrent
63629-2084BaclofenbaclofenBryant Ranch PrepackANDACurrent
63629-2084BaclofenbaclofenBryant Ranch PrepackANDACurrent
63739-974BaclofenbaclofenMcKesson Corporation dba SKY PackagingANDACurrent
63739-974BaclofenbaclofenMcKesson CorporationANDACurrent
66267-872BaclofenbaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-872BaclofenbaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3001BaclofenbaclofenNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3001BaclofenbaclofenNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3001BaclofenbaclofenNuCare Pharmaceuticals, Inc.ANDACurrent
68084-855BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-855BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-855BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-855BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-868BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-868BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-868BaclofenbaclofenAmerican Health PackagingANDACurrent
68084-868BaclofenbaclofenAmerican Health PackagingANDACurrent
68788-6384BaclofenbaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6384BaclofenbaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6384BaclofenbaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6384BaclofenbaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6384BaclofenbaclofenPreferred Pharmaceuticals Inc.ANDACurrent
70518-2173BaclofenbaclofenREMEDYREPACK INC.ANDACurrent
70518-2173BaclofenbaclofenREMEDYREPACK INC.ANDACurrent
70518-2173BaclofenbaclofenREMEDYREPACK INC.ANDACurrent
70518-2173BaclofenbaclofenREMEDYREPACK INC.ANDACurrent
70518-2173BaclofenbaclofenREMEDYREPACK INC.ANDACurrent
71335-0103BaclofenbaclofenBryant Ranch PrepackANDACurrent
71335-0103BaclofenbaclofenBryant Ranch PrepackANDACurrent
71335-0103BaclofenbaclofenBryant Ranch PrepackANDACurrent