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Details for Generic Name: nitroglycerin

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Nitroglycerin is the generic ingredient in fifteen branded drugs marketed by Mist Pharms Llc, Pohl Boskamp, Medicis, Valeant Pharms, Merck Sharp Dohme, Hercon Pharm, Kremers Urban Pharms, Mylan Technologies, Novartis, Sanofi Aventis Us, Abraxis Pharm, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Forest Labs Inc, Fougera, Perrigo Israel, and Pfizer Pharms, and is included in forty NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-eight patent family members in sixteen countries.

There are thirty-six drug master file entries for nitroglycerin. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: nitroglycerin

Drug Master File Entries: see list36
Suppliers / Packaging: see list57
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nitroglycerin

Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

Tentative approvals for NITROGLYCERIN

Applicant Application No. Form Dosage
<disabled><disabled>Film, Extended Release; Transdermal0.2MG/HR
<disabled><disabled>Film, Extended Release; Transdermal0.4MG/HR
<disabled><disabled>Film, Extended Release; Transdermal0.6MG/HR

Clinical Trials for: nitroglycerin

Nitroglycerin in Non-small Cell Lung Cancer
Status: Recruiting Condition: Non Small Cell Lung Cancer (NSCLC)

Treatment of Suspected Cholelithiasis With Nitroglycerin
Status: Not yet recruiting Condition: COLIC; BILIARY TRACT DISEASES

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Status: Completed Condition: Healthy

MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Status: Completed Condition: Healthy

The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women
Status: Recruiting Condition: Contraception; Pain

Nitroglycerin Prevents Radial Artery Occlusion
Status: Completed Condition: Injury of Radial Artery

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Technologies
FILM, EXTENDED RELEASE;TRANSDERMAL074992-004Nov 12, 1999DISCNNo<disabled><disabled>
Pfizer Pharms
TABLET;SUBLINGUAL021134-001May 1, 2000RXNo6,500,456<disabled> <disabled>
Abraxis Pharm
INJECTABLE;INJECTION071203-001May 8, 1987DISCNNo<disabled><disabled>
FILM, EXTENDED RELEASE;TRANSDERMAL089772-001Aug 30, 1996RXNo<disabled><disabled>
Hercon Pharm
FILM, EXTENDED RELEASE;TRANSDERMAL089885-001Oct 30, 1998RXNo<disabled><disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Publication Date
Canada2299231Mar 18, 2003
Germany69721020May 22, 2003
Denmark1019039Mar 25, 2002
Germany202008007318Jul 31, 2008
Canada2718345Sep 17, 2009
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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