MedPath
FDA Approval

NITROGLYCERIN

May 15, 2018

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(0.3 mg in 1 1)

Manufacturing Establishments (1)

Sigmapharm Laboratories, LLC

Sigmapharm Laboratories, LLC

556234636

Products (3)

NITROGLYCERIN

42794-211

ANDA207745

ANDA (C73584)

SUBLINGUAL

May 15, 2018

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.3 mg in 1 1

NITROGLYCERIN

42794-212

ANDA207745

ANDA (C73584)

SUBLINGUAL

May 15, 2018

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT

NITROGLYCERIN

42794-213

ANDA207745

ANDA (C73584)

SUBLINGUAL

May 15, 2018

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.6 mg in 1 1
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