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Nitroglycerin Transdermal Delivery System

Approved
Approval ID

21679c9c-27d7-47c9-828e-b4cc405816cc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 18, 2009

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

nitroglycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-1992
Application NumberANDA089773
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 5, 2011
FDA Product Classification

INGREDIENTS (1)

nitroglycerinActive
Quantity: 10 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM

nitroglycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-3115
Application NumberANDA089771
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 5, 2011
FDA Product Classification

INGREDIENTS (1)

nitroglycerinActive
Quantity: 2.5 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM

nitroglycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-2183
Application NumberANDA089772
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 5, 2011
FDA Product Classification

INGREDIENTS (1)

nitroglycerinActive
Quantity: 5 mg in 1 d
Code: G59M7S0WS3
Classification: ACTIM

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Nitroglycerin Transdermal Delivery System - FDA Drug Approval Details