Orange Book product · Generic (ANDA)
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE
At a glance
Sep 29, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 1987
39 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ISOSORBIDE DINITRATE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ANDA 086031
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ISOSORBIDE DINITRATE
- 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
- 1988ISORDILBrand (NDA)
NDA 012940 · BIOVAIL
- 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
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.
