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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

Tradenames:15
Patents:3
Applicants:22
NDAs:40
Drug Master File Entries: see list36
Suppliers: see list18
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nitroglycerin

Ingredient-typeNitrates
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis
NITROSTAT
nitroglycerin
INJECTABLE;INJECTION018588-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Hospira
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION071846-001Aug 31, 1990RXNo<disabled><disabled>
Rorer
NITROL
nitroglycerin
INJECTABLE;INJECTION018774-001Jan 19, 1983DISCNNo<disabled><disabled>
Forest Labs Inc
RECTIV
nitroglycerin
OINTMENT;INTRA-ANAL021359-001Jun 21, 2011RXYes<disabled><disabled>
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-005Apr 4, 1995RXYes<disabled><disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Publication Date
Spain2169558Jul 01, 2002
Australia9489398Apr 27, 1999
Denmark0927032Jul 14, 2003
Canada2251564Oct 23, 1997
Slovenia1019039Apr 30, 2002
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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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