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NDA

MOLINDONE HYDROCHLORIDE | N017938 | ENDO PHARMACEUTICALS INC

1 strength0 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 DMFs2 inactive

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

PH HEALTH LTDMOLINDONE HYDROCHLORIDE

DMF 194482006

MATRIX PHARMACORP PRIVATE LTDMOLINDONE HYDROCHLORIDE USP

DMF 207752007

CILAG AGInactiveMOLINDONE HYDROCHLORIDE

DMF 79921989

BIOREX RESEARCH DEVELOPMENT COInactiveMOLINDONE HYDROCHLORIDE

DMF 102611993

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 22, 2001	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/ML

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.