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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089367

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NDA 089367 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 089367

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089367

Ingredient-typeNitrates
Physiological EffectVasodilation

Medical Subject Heading (MeSH) Categories for 089367

Suppliers and Packaging for NDA: 089367

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 089367 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7903 0615-7903-39 30 TABLET in 1 BLISTER PACK (0615-7903-39)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 089367 ANDA Sandoz Inc 0781-1695 0781-1695-10 1000 TABLET in 1 BOTTLE (0781-1695-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 7, 1988TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Julphar
McKesson
Daiichi Sankyo
Chubb
Accenture
Teva
Johnson and Johnson
Fuji
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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