FDA.reportPublic FDA data

Application 040062

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHAZOLAMIDEMETHAZOLAMIDETABLET;ORAL25MGNoNo
002METHAZOLAMIDEMETHAZOLAMIDETABLET;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0790methazolamidemethazolamidePadagis US LLCANDACurrent
0574-0790methazolamidemethazolamidePaddock Laboratories, LLCANDACurrent
0574-0791methazolamidemethazolamidePaddock Laboratories, LLCANDACurrent
0574-0791methazolamidemethazolamidePadagis US LLCANDACurrent
46672-109MethazolamidemethazolamideMikart, LLCANDACurrent
46672-109MethazolamidemethazolamideMikart, LLCANDACurrent
46672-109MethazolamidemethazolamideMikart, LLCANDACurrent
46672-110MethazolamidemethazolamideMikart, LLCANDACurrent
46672-110MethazolamidemethazolamideMikart, LLCANDACurrent
46672-110MethazolamidemethazolamideMikart, LLCANDACurrent
50090-3233methazolamidemethazolamideA-S Medication SolutionsANDACurrent
50090-3233methazolamidemethazolamideA-S Medication SolutionsANDACurrent
55806-020methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
55806-020methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
55806-020methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
55806-021methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
55806-021methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
55806-021methazolamidemethazolamideEffcon Laboratories, Inc.ANDACurrent
68151-3110MethazolamidemethazolamideCarilion Materials ManagementANDACurrent