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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087946

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NDA 087946 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 NDA: 087946

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

Pharmacology for NDA: 087946

Ingredient-typeNitrates
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 087946

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE
isosorbide dinitrate
 TABLET;ORAL 087946 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7584 0615-7584-39 30 TABLET in 1 BLISTER PACK (0615-7584-39)
ISOSORBIDE DINITRATE
isosorbide dinitrate
 TABLET;ORAL 087946 ANDA AvKARE, Inc. 42291-350 42291-350-01 100 TABLET in 1 BOTTLE (42291-350-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jan 12, 1988TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Colorcon
Medtronic
AstraZeneca
Federal Trade Commission
Mallinckrodt
Dow
Daiichi Sankyo
Baxter

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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