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Serving leading biopharmaceutical companies globally:

US Army
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Novartis
Dow
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208191

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NDA 208191 describes NITROGLYCERIN, which is a drug marketed by Hercon Pharm, Kremers Urban Pharms, Mylan Technologies, Abraxis Pharm, Hospira, Intl Medication, Luitpold, Smith And Nephew, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Dr Reddys Labs Inc, Glenmark Pharms Ltd, and Baxter Hlthcare, and is included in twenty-four NDAs. It is available from seventeen suppliers. Additional details are available on the NITROGLYCERIN profile page.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 208191
Tradename:NITROGLYCERIN
Applicant:Dr Reddys Labs Inc
Ingredient:nitroglycerin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 208191
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 208191
Suppliers and Packaging for NDA: 208191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191 ANDA Dr. Reddys Laboratories Inc 43598-435 43598-435-01 100 TABLET in 1 BOTTLE (43598-435-01)
NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191 ANDA Dr. Reddys Laboratories Inc 43598-436 43598-436-11 4 BOTTLE in 1 CARTON (43598-436-11) > 25 TABLET in 1 BOTTLE (43598-436-35)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.3MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.4MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.6MG
Approval Date:Aug 26, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
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Colorcon
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McKinsey
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