Orange Book product · Generic (ANDA)
ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE
At a glance
Nov 07, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 2022
3 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ISOSORBIDE MONONITRATE
Strength
30MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 216557
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ISOSORBIDE MONONITRATE
- 1993IMDURBrand (NDA)
NDA 020225 · SCHERING PLOUGH
- 1993MONOKETBrand (NDA)
NDA 020215 · OMNIVIUM PHARMS
- 1991ISMOBrand (NDA)
NDA 019091 · PROMIUS PHARMA
- 2026ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 075147 · ANI PHARMS
- 2024ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 218255 · ZYDUS PHARMS
- 2024ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 214115 · SHANDONG
- 2018ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 210918 · RICONPHARMA LLC
- 2018ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 210822 · DEXCEL LTD
- 2017ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 209684 · ACCORD HLTHCARE
- 2016ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 075522 · DEXCEL LTD
- 2011ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 200270 · TORRENT PHARMS
- 2011ISOSORBIDE MONONITRATEGeneric (ANDA)
ANDA 200495 · TORRENT 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.
