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Last Updated: August 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213057

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NDA 213057 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from seventeen 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 suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 213057
Tradename:ISOSORBIDE DINITRATE
Applicant:Zydus
Ingredient:isosorbide dinitrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213057
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 213057
Suppliers and Packaging for NDA: 213057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 213057 ANDA Northstar Rx LLC 16714-007 16714-007-01 100 TABLET in 1 BOTTLE (16714-007-01)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 213057 ANDA Northstar Rx LLC 16714-008 16714-008-01 100 TABLET in 1 BOTTLE (16714-008-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 20, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 20, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 20, 2019TE:ABRLD:No

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