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ISORDIL

NDA

ISOSORBIDE DINITRATE | N012940 | BIOVAIL LABORATORIES INC

3 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 Chain2 active DMFs8 inactive

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

DIPHARMA FRANCIS SRLISOSORBIDE DINITRATE (ISDN)

DMF 37251980

EIRCHEM PHARMA SERVICES LTDISOSORBIDE DINITRATE DILUTED

DMF 92281991

NYSCO LABS INCInactiveISOSORBIDE DINITRATE TIMED RELEASE PELLETS

DMF 10211967

NAPP-LEMKE CHEMS INCInactiveISOSORBIDE DINITRATE

DMF 17911971

EUTICALS LTDInactiveISOSORBIDE DINITRATE BULK

DMF 18551972

PALMER RESEARCH LABORATORIESInactiveISOSORBIDE DINITRATE TRITURATE

DMF 18571972

BOFORS INDSInactiveISOSORBIDE DINITRATE

DMF 22381974

SANOL SCHWARZInactiveISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION

DMF 42241981

LYPHOMED INCInactiveISOSORBIDE DINITRATE INJECTION (50ML AND 100ML)

DMF 57611985

INDUSTRIAS QUIMICAS TAUBATE SAInactiveISOSORBIDE DINITRATE

DMF 77071988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 16, 2001	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Jul 29, 1988

No patent or exclusivity listings for this strength.

#004 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Jul 29, 1988

#005 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Jul 29, 1988