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LEVO-DROMORAN

NDA

LEVORPHANOL TARTRATE | N008720 | VALEANT PHARMACEUTICALS INTERNATIONAL

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1-Orange Book re: Suitability Petition from Nostrum Laboratories, ... FDA-2023-P-4617 · 7 docket documents Nostrum Laboratories, Inc. filed a petition requesting FDA confirmation that generic versions of levorphanol tartrate oral solutions are suitable for abbreviated new drug application (ANDA) approval, seeking to establish bioequivalence to reference products and clarify the regulatory pathway for thi	Suitability	2023-10-24	Denied	Nostrum Laboratories, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer NCT03579446	Early Phase 1	Terminated	M.D. Anderson Cancer Center	43	2018-11-29 → 2023-06-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs3 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCLEVORPHANOL TARTRATE USP SPECIAL

DMF 188232005

NOVITIUM PHARMA LLCLEVORPHANOL TARTRATE USP

DMF 332242018

AMPAC FINE CHEMICALS LLCLEVORPHANOL TARTRATE DRUG SUBSTANCE

DMF 343042020

NORAMCO LLCLEVORPHANOL TARTRATE

DMF 359772021

HOFFMANN LA ROCHE INCInactiveLEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL.

DMF 37261980

MALLINCKRODT PHARMS DIV MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 76251988

MALLINCKRODT INCInactiveLEVORPHANOL TARTRATE

DMF 99681992

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 7, 2004	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 19, 1991

No patent or exclusivity listings for this strength.