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Details for New Drug Application (NDA): 086169

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NDA 086169 describes ISOSORBIDE DINITRATE, which is a drug marketed by Sun Pharm Inds, Sun Pharm Inds Inc, Sandoz, Corepharma, Par Pharm, Watson Labs, Hikma Intl Pharms, and Superpharm, and is included in thirty-one NDAs. It is available from twenty-five 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-eight suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

Summary for NDA: 086169

Tradename:
ISOSORBIDE DINITRATE
Applicant:
Sun Pharm Inds
Ingredient:
isosorbide dinitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Sep 19, 1986TE:RLD:No


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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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