FDA.report

Application 040411

Type
ANDA
Sponsor
CASI PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001METHIMAZOLEMETHIMAZOLETABLET;ORAL5MGNoNo
002METHIMAZOLEMETHIMAZOLETABLET;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0205MethimazoleMethimazoleEon Labs, Inc.ANDACurrent
0185-0210MethimazoleMethimazoleEon Labs, Inc.ANDACurrent
0615-6500MethimazoleMethimazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7613MethimazoleMethimazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50436-7066MethimazoleMethimazoleUnit Dose ServicesANDACurrent
62135-205MethimazoleMethimazoleChartwell RX, LLCANDACurrent
62135-205MethimazoleMethimazoleChartwell RX, LLCANDACurrent
62135-206MethimazoleMethimazoleChartwell RX, LLCANDACurrent
62135-206MethimazoleMethimazoleChartwell RX, LLCANDACurrent
68084-275MethimazoleMethimazoleAmerican Health PackagingANDACurrent
68084-276MethimazoleMethimazoleAmerican Health PackagingANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
299510ORIG12001-03-27FDA source fallback