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Serving leading biopharmaceutical companies globally:

Medtronic
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Generated: January 21, 2018

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 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-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
Tradename:ISOSORBIDE DINITRATE
Applicant:Hikma Intl Pharms
Ingredient:isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 088088
Ingredient-typeNitrates
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 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 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)

Profile 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:

Moodys
Chinese Patent Office
Deloitte
Cantor Fitzgerald
Boehringer Ingelheim
Colorcon
Farmers Insurance
Express Scripts
Fuji

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