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DELSYM

NDA

DEXTROMETHORPHAN POLISTIREX | N018658 | RECKITT BENCKISER 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

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 7 NDCs (7 FSS)

Lowest Price

$4.83

Highest Price

$8.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63824-0171-63DELSYM 12 HOUR (GRAPE)	$6.51	FSS	RB Health (US) LLC	06/14/2027
63824-0171-65DELSYM 12 HOUR (GRAPE)	$8.60	FSS	RB Health (US) LLC	06/14/2027
63824-0173-63CHILDREN'S DELSYM COUGH (GRAPE)	$6.51	FSS	RB Health (US) LLC	06/14/2027
63824-0173-65CHILDREN'S DELSYM COUGH (GRAPE)	$8.60	FSS	RB Health (US) LLC	06/14/2027
63824-0175-63DELSYM 12 HOUR (ORANGE)	$4.83	FSS	RB Health (US) LLC	06/14/2027
63824-0175-65DELSYM 12 HOUR (ORANGE)	$8.60	FSS	RB Health (US) LLC	06/14/2027
63824-0177-63CHILDREN'S DELSYM (ORANGE)	$6.51	FSS	RB Health (US) LLC	06/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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.