MedPath
FDA Approval

NITROGLYCERIN

November 1, 2023

Human Prescription Drug Label

Nitroglycerin(0.4 mg in 1 1)

Manufacturing Establishments (1)

APL HEALTHCARE LIMITED

Aurobindo Pharma Limited

650918514

Products (3)

NITROGLYCERIN

59651-658

ANDA217879

ANDA (C73584)

SUBLINGUAL

November 1, 2023

Code: G59M7S0WS3Class: ACTIBQuantity: 0.4 mg in 1 1
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT

NITROGLYCERIN

59651-657

ANDA217879

ANDA (C73584)

SUBLINGUAL

November 1, 2023

Code: G59M7S0WS3Class: ACTIBQuantity: 0.3 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

NITROGLYCERIN

59651-659

ANDA217879

ANDA (C73584)

SUBLINGUAL

November 1, 2023

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.6 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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