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Serving leading biopharmaceutical companies globally:

Fuji
Queensland Health
Teva
QuintilesIMS
Covington
Julphar
UBS
Cerilliant
Cipla
Medtronic

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086055

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NDA 086055 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 086055

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

Pharmacology for NDA: 086055

Ingredient-typeNitrates
Physiological EffectVasodilation

Medical Subject Heading (MeSH) Categories for 086055

Suppliers and Packaging for NDA: 086055

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086055 ANDA West-ward Pharmaceutical Corp 0143-1767 0143-1767-10 1000 TABLET in 1 BOTTLE (0143-1767-10)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086055 ANDA West-ward Pharmaceutical Corp 0143-1767 0143-1767-01 100 TABLET in 1 BOTTLE (0143-1767-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength5MG
Approval Date:Nov 2, 1987TE:RLD:No


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Serving leading biopharmaceutical companies globally:

US Army
Healthtrust
Merck
Argus Health
Julphar
Fish and Richardson
Colorcon
AstraZeneca
Medtronic
Johnson and Johnson

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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