FDA.reportPublic FDA data

Application 207438

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHAZOLAMIDEMETHAZOLAMIDETABLET;ORAL25MGNoNo
002METHAZOLAMIDEMETHAZOLAMIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-022MethazolamidemethazolamideBausch & Lomb IncorporatedANDACurrent
24208-023MethazolamidemethazolamideBausch & Lomb IncorporatedANDACurrent
42571-239METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-239METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-239METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-239METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-240METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-240METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-240METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
42571-240METHAZOLAMIDEMethazolamideMicro Labs LimitedANDACurrent
68682-022MethazolamidemethazolamideOceanside PharmaceuticalsANDACurrent
68682-023MethazolamidemethazolamideOceanside PharmaceuticalsANDACurrent