FDA.report

Application 075280

Type
ANDA
Sponsor
CASI PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0145NabumetoneNabumentoneEon Labs, Inc.ANDACurrent
0185-0146NabumetoneNabumentoneEon Labs, Inc.ANDACurrent
35356-685NabumetoneNabumentoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-685NabumetoneNabumentoneLake Erie Medical DBA QuaANDACurrent
55289-609NabumetoneNabumentonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-609NabumetoneNabumentonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-609NabumetoneNabumentonePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-609NabumetoneNabumentonePD-Rx Pharmaceuticals, Inc.ANDACurrent
60760-184NabumetoneNabumentoneSt. Mary's Medical Park PharmacyANDACurrent
60760-185NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
61919-609NABUMETONENABUMETONEDIRECT RXANDACurrent
68084-051NabumetoneNabumentoneAmerican Health PackagingANDACurrent
70518-0614NabumetoneNabumentoneREMEDYREPACK INC.ANDACurrent
70518-0614NabumetoneNabumentoneREMEDYREPACK INC.ANDACurrent
70518-0698NabumetoneNabumentoneREMEDYREPACK INC.ANDACurrent
70518-0698NabumetoneNabumentoneREMEDYREPACK INC.ANDACurrent
71205-378NabumetoneNabumentoneProficient Rx LPANDACurrent
71335-0754NabumetoneNabumentoneBryant Ranch PrepackANDACurrent
71335-0754NabumetoneNabumentoneBryant Ranch PrepackANDACurrent
71335-0781NabumetoneNabumentoneBryant Ranch PrepackANDACurrent
71335-0781NabumetoneNabumentoneBryant Ranch PrepackANDACurrent
71335-0939NabumetoneNabumentoneBryant Ranch PrepackANDACurrent
71335-0939NabumetoneNabumentoneBryant Ranch PrepackANDACurrent

Documents

DocumentSubmission typeDate
8595ORIG2004-06-09
8596ORIG2003-04-10