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ORLAAM

NDA

LEVOMETHADYL ACETATE HYDROCHLORIDE | N020315 | ROXANE LABORATORIES 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 Chain0 active DMFs1 inactive

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

ORPHARM INCInactiveLEVOMETHADYL ACETATE HYDROCHLORIDE (LAAM HCL)

DMF 127411997

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 30, 2001	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Jul 9, 1993

No patent or exclusivity listings for this strength.