FDA.reportPublic FDA data

Application 211555

Type
ANDA
Sponsor
EYWA PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-0060BaclofenBaclofenUnit Dose ServicesANDACurrent
60687-503BaclofenBaclofenAmerican Health PackagingANDACurrent
60687-503BaclofenBaclofenAmerican Health PackagingANDACurrent
60687-503BaclofenBaclofenAmerican Health PackagingANDACurrent
60687-514BaclofenBaclofenAmerican Health PackagingANDACurrent
60687-514BaclofenBaclofenAmerican Health PackagingANDACurrent
60687-514BaclofenBaclofenAmerican Health PackagingANDACurrent
68071-2289BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2289BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5252BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5252BaclofenBaclofenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7635BaclofenBaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7635BaclofenBaclofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7643BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7643BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2662BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-2662BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-2662BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-2804BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
70518-2804BaclofenBaclofenREMEDYREPACK INC.ANDACurrent
71335-1643BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1643BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1643BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1664BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1664BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-1664BaclofenBaclofenBryant Ranch PrepackANDACurrent
71930-006BaclofenBaclofenEywa Pharma IncANDACurrent
71930-006BaclofenBaclofenEywa Pharma IncANDACurrent
71930-006BaclofenBaclofenEywa Pharma IncANDACurrent
71930-006BaclofenBaclofenEywa Pharma IncANDACurrent
71930-007BaclofenBaclofenEywa Pharma IncANDACurrent
71930-007BaclofenBaclofenEywa Pharma IncANDACurrent
71930-007BaclofenBaclofenEywa Pharma IncANDACurrent
71930-007BaclofenBaclofenEywa Pharma IncANDACurrent
71930-066BaclofenBaclofenEywa Pharma IncANDACurrent
80175-0006BaclofenBaclofenCentral PackagingANDACurrent