MedPath
FDA Approval

Nitroglycerin Transdermal Delivery System

November 18, 2009

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(2.5 mg in 1 d)

Registrants (1)

Graceway Pharmaceuticals, LLC

613448161

Manufacturing Establishments (1)

3M Drug Delivery Systems

Graceway Pharmaceuticals, LLC

Graceway Pharmaceuticals, LLC

128688199

Products (4)

Nitroglycerin Transdermal Delivery System

29336-321

ANDA089771

ANDA (C73584)

TRANSDERMAL

November 23, 2009

Code: G59M7S0WS3Class: ACTIMQuantity: 2.5 mg in 1 d

Nitroglycerin Transdermal Delivery System

29336-324

ANDA089774

ANDA (C73584)

TRANSDERMAL

November 23, 2009

Code: G59M7S0WS3Class: ACTIMQuantity: 15 mg in 1 d

Nitroglycerin Transdermal Delivery System

29336-323

ANDA089773

ANDA (C73584)

TRANSDERMAL

November 23, 2009

Code: G59M7S0WS3Class: ACTIMQuantity: 10 mg in 1 d

Nitroglycerin Transdermal Delivery System

29336-322

ANDA089772

ANDA (C73584)

TRANSDERMAL

November 23, 2009

Code: G59M7S0WS3Class: ACTIMQuantity: 5 mg in 1 d
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