FDA.report

Application 075994

Type
ANDA
Sponsor
CASI PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRILLISINOPRILTABLET;ORAL2.5MGNoNo
002LISINOPRILLISINOPRILTABLET;ORAL5MGNoNo
003LISINOPRILLISINOPRILTABLET;ORAL10MGNoNo
004LISINOPRILLISINOPRILTABLET;ORAL20MGNoNo
005LISINOPRILLISINOPRILTABLET;ORAL30MGNoNo
006LISINOPRILLISINOPRILTABLET;ORAL40MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0025lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0101lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0102lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0103lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0104lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0602lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0605lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0610lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0620lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0630lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-0640lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0185-5400lisinoprillisinoprilEon Labs, Inc.ANDACurrent
0615-7774lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7775lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7776lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7777lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7778lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7779lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7917LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7918lisinoprillisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7934LisinoprilLisinoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-5811lisinoprillisinoprilMajor PharmaceuticalsANDACurrent
0904-6485lisinoprillisinoprilMajor PharmaceuticalsANDACurrent
0904-6486lisinoprillisinoprilMajor PharmaceuticalsANDACurrent
0904-6487lisinoprillisinoprilMajor PharmaceuticalsANDACurrent
10544-903lisinoprillisinoprilBlenheim Pharmacal, Inc.ANDACurrent
10544-904lisinoprillisinoprilBlenheim Pharmacal, Inc.ANDACurrent
10544-905lisinoprillisinoprilBlenheim Pharmacal, Inc.ANDACurrent
33261-373lisinoprillisinoprilAidarex Pharmaceuticals LLCANDACurrent
33358-212lisinoprillisinoprilRxChange Co.ANDACurrent
33358-213lisinoprillisinoprilRxChange Co.ANDACurrent
48433-332lisinoprillisinoprilSafecor Health, LLCANDACurrent
50090-2952lisinoprillisinoprilA-S Medication SolutionsANDACurrent
50436-7988lisinoprillisinoprilUnit Dose ServicesANDACurrent
51655-402LISINOPRILLISINOPRILNorthwind Pharmaceuticals, LLCANDACurrent
51655-408LISINOPRILLISINOPRILNorthwind Pharmaceuticals, LLCANDACurrent
53808-0999lisinoprillisinoprilState of Florida DOH Central PharmacyANDACurrent
55154-3331lisinoprillisinoprilCardinal HealthANDACurrent
55154-7639lisinoprillisinoprilCardinal HealthANDACurrent
55154-7641lisinoprillisinoprilCardinal HealthANDACurrent
55154-7641lisinoprillisinoprilCardinal HealthANDACurrent
61919-161LISINOPRILLISINOPRILDIRECT RXANDACurrent
61919-161LISINOPRILLISINOPRILDIRECT RXANDACurrent
61919-356LISINOPRILLISINOPRILDirectRXANDACurrent
61919-942LISINOPRILLISINOPRILDIRECT RXANDACurrent
61919-942LISINOPRILLISINOPRILDIRECT RXANDACurrent
63187-722lisinoprillisinoprilProficient Rx LPANDACurrent
63187-722lisinoprillisinoprilProficient Rx LPANDACurrent
64725-1020lisinoprillisinoprilTYA PharmaceuticalsANDACurrent
64725-5400lisinoprillisinoprilTYA PharmaceuticalsANDACurrent
66267-583lisinoprillisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-583lisinoprillisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
67296-0630lisinoprillisinoprilRedPharm Drug Inc.ANDACurrent
68001-267lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-267lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-268lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-268lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-269lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-269lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-270lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-270lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-271lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-271lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-272lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68001-272lisinoprillisinoprilBluePoint LaboratoriesANDACurrent
68071-3070lisinoprillisinoprilNuCare Pharmaceuticals, Inc.ANDACurrent
68151-4290lisinoprillisinoprilCarilion Materials ManagementANDACurrent
68788-8914lisinoprillisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8943lisinoprillisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
68788-9765lisinoprillisinoprilPreferred Pharmaceuticals Inc.ANDACurrent
70518-1268lisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70518-1268lisinoprillisinoprilREMEDYREPACK INC.ANDACurrent
70882-103lisinoprillisinoprilCambridge Therapeutics Technologies, LLCANDACurrent
70882-104LisinoprillisinoprilCambridge Therapeutics Technologies, LLCANDACurrent
70882-110lisinoprillisinoprilCambridge Therapeutics Technologies, LLCANDACurrent

Documents

DocumentSubmission typeDate
31057ORIG2004-06-08