Orange Book product · Brand (NDA)
ISORDIL
ISOSORBIDE DINITRATE
At a glance
Jul 29, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 1988
38 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ISOSORBIDE DINITRATE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 012940
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1996SORBITRATEBrand (NDA)
NDA 016776 · ASTRAZENECA
- 1996SORBITRATEBrand (NDA)
NDA 016192 · ASTRAZENECA
- 1996SORBITRATEBrand (NDA)
NDA 016191 · ASTRAZENECA
- 1988DILATRATE-SRBrand (NDA)
NDA 019790 · ENDO OPERATIONS
- 1988ISORDILBrand (NDA)
NDA 012882 · WYETH AYERST
- 1988ISORDILBrand (NDA)
NDA 012093 · BAUSCH
- 2022ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 215723 · RUBICON RESEARCH
- 2021ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 211290 · PH HEALTH
- 2019ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 213057 · ZYDUS LIFESCIENCES
- 2008ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 040723 · IMPAX LABS INC
- 2007ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 040591 · HIKMA INTL PHARMS
- 1998ISOSORBIDE DINITRATEGeneric (ANDA)
ANDA 040009 · SUN PHARM INDS INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
