Viewing data from:

MONOKET

NDA

ISOSORBIDE MONONITRATE | N020215 | OMNIVIUM PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)

DMF 208162007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 4, 2022	SUPPL -27	View Letter (PDF)
Oct 3, 2014	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 30, 1993

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 30, 1993