MedPath
FDA Approval

Nitroglycerin

October 21, 2021

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(0.6 mg in 1 1)

Manufacturing Establishments (1)

Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Inc., USA

862603186

Products (3)

Nitroglycerin

68462-640

ANDA206391

ANDA (C73584)

SUBLINGUAL

October 21, 2021

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.6 mg in 1 1
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT

Nitroglycerin

68462-638

ANDA206391

ANDA (C73584)

SUBLINGUAL

October 21, 2021

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.3 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT

Nitroglycerin

68462-639

ANDA206391

ANDA (C73584)

SUBLINGUAL

October 21, 2021

Code: G59M7S0WS3Class: ACTIBQuantity: 0.4 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0WClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
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