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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
Daiichi Sankyo
Argus Health
McKinsey
Mallinckrodt
Harvard Business School
Cipla
Farmers Insurance

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087946

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NDA 087946 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, and Watson Labs Teva, and is included in thirty-one NDAs. It is available from twenty-three suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 087946
Tradename:ISOSORBIDE DINITRATE
Applicant:Par Pharm
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087946
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 087946
Suppliers and Packaging for NDA: 087946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087946 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7584 N 0615-7584-39
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087946 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8193 N 0615-8193-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jan 12, 1988TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Fuji
Medtronic
Federal Trade Commission
Citi
Deloitte
Dow
Cipla

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