FDA.reportPublic FDA data

Application 075229

Type
ANDA
Sponsor
CASI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL50MGNoNo
002DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMTABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5017Diclofenac PotassiumDiclofenac PotassiumSandoz IncANDACurrent
12634-827DICLOFENAC POTASSIUMDICLOFENAC POTASSIUMAPOTHECA, INCANDACurrent
50090-0647Diclofenac PotassiumDiclofenac PotassiumA-S Medication SolutionsANDACurrent
50090-5893Diclofenac Potassiumdiclofenac potassiumA-S Medication SolutionsANDACurrent
55289-781Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-781Diclofenac PotassiumDiclofenac PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-989Diclofenac Potassiumdiclofenac potassiumQuality Care Products, LLCANDACurrent
68071-2625Diclofenac Potassiumdiclofenac potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2625Diclofenac Potassiumdiclofenac potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
71335-2052Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
71335-2052Diclofenac Potassiumdiclofenac potassiumBryant Ranch PrepackANDACurrent
72888-073Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
72888-073Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
72888-073Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
72888-073Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
72888-073Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
72888-086Diclofenac Potassiumdiclofenac potassiumAdvagen Pharma LtdANDACurrent
74157-007Diclofenac Potassiumdiclofenac potassiumINA Pharmaceutics IncANDACurrent
74157-007Diclofenac Potassiumdiclofenac potassiumINA Pharmaceutics IncANDACurrent
74157-007Diclofenac Potassiumdiclofenac potassiumINA Pharmaceutics IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8571ORIG1998-11-20