Viewing data from:

OXSORALEN-ULTRA

NDA

METHOXSALEN | N019600 | BAUSCH HEALTH AMERICAS 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 DMFs4 inactive

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

WANBURY LTDMETHOXSALEN

DMF 200382006

SOLARA ACTIVE PHARMA SCIENCES LTDMETHOXSALEN USP

DMF 218622008

MEMPHIS CHEMICAL COInactiveMETHOXSALEN USP

DMF 29341977

FRANCO INDIAN PHARMACEUTICALS PVT LTDInactiveMETHOXSALEN

DMF 35641979

OY STAR ABInactiveMETHOXSALEN

DMF 47921983

CHEMPACIFIC CORPInactiveMETHOXSALEN DRUG SUBSTANCE

DMF 193502006

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 15, 2003	SUPPL -6	View Letter (PDF)
Apr 15, 2003	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 30, 1986

No patent or exclusivity listings for this strength.