FDA.report

Application 040350

Type
ANDA
Sponsor
MYLAN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001METHIMAZOLEMETHIMAZOLETABLET;ORAL5MGNoNo
002METHIMAZOLEMETHIMAZOLETABLET;ORAL10MGNoYes
003METHIMAZOLEMETHIMAZOLETABLET;ORAL20MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-008MethimazolemethimazoleRebel Distributors Corp.ANDACurrent
42254-009MethimazolemethimazoleRebel Distributors Corp.ANDACurrent
49884-640MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-640MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-640MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-640MethimazolemethimazolePar Pharmaceutical, Inc.ANDACurrent
49884-640MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-641MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-641MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-641MethimazolemethimazolePar PharmaceuticalANDACurrent
49884-641MethimazolemethimazolePar Pharmaceutical, Inc.ANDACurrent
49884-641MethimazolemethimazolePar PharmaceuticalANDACurrent
50090-2366MethimazolemethimazoleA-S Medication SolutionsANDACurrent
50090-2366MethimazolemethimazoleA-S Medication SolutionsANDACurrent
50090-3334MethimazolemethimazoleA-S Medication SolutionsANDACurrent
50090-3334MethimazolemethimazoleA-S Medication SolutionsANDACurrent
53808-0850MethimazolemethimazoleState of Florida DOH Central PharmacyANDACurrent
60687-357MethimazolemethimazoleAmerican Health PackagingANDACurrent
60687-357MethimazolemethimazoleAmerican Health PackagingANDACurrent
60687-357MethimazoleMethimazoleAmerican Health PackagingANDACurrent
60687-357MethimazoleMethimazoleAmerican Health PackagingANDACurrent
60687-370MethimazolemethimazoleAmerican Health PackagingANDACurrent
60687-370MethimazolemethimazoleAmerican Health PackagingANDACurrent
60687-370MethimazoleMethimazoleAmerican Health PackagingANDACurrent
60687-370MethimazoleMethimazoleAmerican Health PackagingANDACurrent
60687-669MethimazolemethimazoleAmerican Health PackagingANDACurrent
60687-680MethimazolemethimazoleAmerican Health PackagingANDACurrent
63629-2224MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-2224MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-2224MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-2225MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-2225MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-2225MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-4331MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-6408MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-6408MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-6408MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9137MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9137MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9137MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9249MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9249MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9250MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9250MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9250MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9251MethimazolemethimazoleBryant Ranch PrepackANDACurrent
63629-9251MethimazolemethimazoleBryant Ranch PrepackANDACurrent
64380-212MethimazolemethimazoleStrides Pharma Science LimitedANDACurrent
64380-212MethimazolemethimazoleStrides Pharma Science LimitedANDACurrent
64380-213MethimazolemethimazoleStrides Pharma Science LimitedANDACurrent
64380-213MethimazolemethimazoleStrides Pharma Science LimitedANDACurrent
64980-260MethimazolemethimazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-260MethimazolemethimazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-261MethimazolemethimazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-261MethimazolemethimazoleRising Pharmaceuticals, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
17774SUPPL2015-08-14
42619SUPPL2005-07-22
42618ORIG2005-07-22
22133SUPPL2005-07-22
22132SUPPL2005-07-22
7631ORIG2000-03-29