Orange Book product · Generic (ANDA)
ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE
At a glance
Jul 08, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 08, 2022
4 yr ago
Today
Pharmaceutical detail
Active ingredient
ISOSORBIDE DINITRATE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215723
Product number
001
Marketing status
RX
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
- 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.
