MedPath
FDA Approval

Nitroglycerin

February 10, 2017

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(0.3 mg in 1 1)

Manufacturing Establishments (1)

Ingenus Pharmaceuticals NJ, LLC

Dr. Reddys Laboratories Inc

964680206

Products (3)

Nitroglycerin

43598-435

ANDA208191

ANDA (C73584)

SUBLINGUAL

February 10, 2017

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.3 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EAClass: IACT

Nitroglycerin

43598-436

ANDA208191

ANDA (C73584)

SUBLINGUAL

February 10, 2017

Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EAClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.4 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT

Nitroglycerin

43598-437

ANDA208191

ANDA (C73584)

SUBLINGUAL

February 10, 2017

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.6 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EAClass: IACT
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