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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086054

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NDA 086054 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 086054
Applicant:Hikma Intl Pharms
Ingredient:isosorbide dinitrate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 086054
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 086054
Suppliers and Packaging for NDA: 086054
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086054 ANDA West-ward Pharmaceutical Corp 0143-1765 N 0143-1765-01
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086054 ANDA West-ward Pharmaceutical Corp 0143-1765 N 0143-1765-25

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength2.5MG
Approval Date:Oct 29, 1987TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Farmers Insurance
Chinese Patent Office
Express Scripts

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