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DELSYM

NDA

DEXTROMETHORPHAN POLISTIREX | N018658 | RB HEALTH US LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study NCT06736509	Phase 3	Terminated	Axsome Therapeutics, Inc.	139	2024-11-21 → 2025-04-25

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

API Supply Chain3 active DMFs1 inactive

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

SOLARA ACTIVE PHARMA SCIENCES LTDDEXTROMETHORPHAN POLISTIREX

DMF 292162015

APITORIA PHARMA PRIVATE LTDDEXTROMETHORPHAN POLISTIREX

DMF 379102022

DASAMI LAB PRIVATE LTDDEXTROMETHORPHAN POLISTIREX

DMF 412862025

CAMBREX CHARLES CITY INCInactiveDEXTROMETHORPHAN POLISTIREX

DMF 223292008

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2024	SUPPL -34	View Letter (PDF)
Aug 13, 2020	SUPPL -31	View Letter (PDF)
Aug 11, 2014	SUPPL -30	View Letter (PDF)
May 19, 2011	SUPPL -29	View Letter (PDF)
Nov 15, 2010	SUPPL -28	View Letter (PDF)
Apr 13, 2010	SUPPL -27	View Letter (PDF)
Nov 12, 2009	SUPPL -26	View Letter (PDF)
Dec 10, 2008	SUPPL -23	View Letter (PDF)
Oct 4, 2007	SUPPL -22	View Letter (PDF)
Mar 10, 2005	SUPPL -18	View Letter (PDF)
Nov 16, 2004	SUPPL -17	View Letter (PDF)
Jan 24, 2002	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 30MG HYDROBROMIDE/5ML

RLD

0 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;ORAL | Approved: Oct 8, 1982

No patent or exclusivity listings for this strength.