Application 200495

Type
ANDA
Sponsor
TORRENT PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETABLET, EXTENDED RELEASE;ORAL120MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7768ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7768ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-6450ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEMajor PharmaceuticalsANDACurrent
0904-6450ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEMajor PharmaceuticalsANDACurrent
0904-6451ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEMajor PharmaceuticalsANDACurrent
10544-243ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATEBlenheim Pharmacal, Inc.ANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-105ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
13668-106ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATETorrent Pharmaceuticals LimitedANDACurrent
55154-7292ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal HealthANDACurrent
55154-7292ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal HealthANDACurrent
55154-7292ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal HealthANDACurrent
55154-7292ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal HealthANDACurrent
55154-7292ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATECardinal Health 107, LLCANDACurrent