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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-seven 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 list37
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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-005Feb 27, 1996DISCNNo<disabled><disabled>
Hospira
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION071846-001Aug 31, 1990RXNo<disabled><disabled>
Smith And Nephew
NITROGLYCERIN
nitroglycerin
INJECTABLE;INJECTION070633-001Jun 19, 1986DISCNNo<disabled><disabled>
Luitpold
NITROGLYCERIN
nitroglycerin
INJECTABLE;INJECTION071492-001May 24, 1988DISCNNo<disabled><disabled>
Abraxis Pharm
NITROGLYCERIN
nitroglycerin
INJECTABLE;INJECTION070077-001Dec 13, 1985DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Publication Date
Spain2169558Jul 01, 2002
Israel134395Apr 30, 2001
Austria237322May 15, 2003
Canada2251564Oct 23, 1997
Spain2197990Jan 16, 2004
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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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