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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
US Department of Justice
Queensland Health

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088088

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NDA 088088 describes ISOSORBIDE DINITRATE, which is a drug marketed by Sun Pharm Inds, Sun Pharm Inds Inc, Sandoz, Impax Labs Inc, Par Pharm, Watson Labs Teva, Watson Labs, Hikma Intl Pharms, and Superpharm, and is included in thirty-one NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

Summary for 088088

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 088088

Physiological EffectVasodilation

Medical Subject Heading (MeSH) Categories for 088088

Suppliers and Packaging for NDA: 088088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
isosorbide dinitrate
TABLET;ORAL 088088 ANDA West-Ward Pharmaceuticals Corp 0143-1772 0143-1772-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1772-01)
isosorbide dinitrate
TABLET;ORAL 088088 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1575 0615-1575-39 30 TABLET in 1 BLISTER PACK (0615-1575-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 2, 1987TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Chinese Patent Office
Express Scripts
Fish and Richardson
Harvard Business School
US Army

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