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MUCINEX D

NDA

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | N021585 | RB HEALTH US LLC

2 strengths0 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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 9, 2024	SUPPL -38	View Letter (PDF)
Oct 1, 2019	SUPPL -30	View Letter (PDF)
Dec 1, 2017	SUPPL -33	View Letter (PDF)
Mar 7, 2014	SUPPL -26	View Letter (PDF)
Dec 22, 2010	SUPPL -25	View Letter (PDF)
Sep 7, 2007	SUPPL -12	View Letter (PDF)
Mar 3, 2005	SUPPL -1	View Letter (PDF)
Jan 26, 2005	SUPPL -2	View Letter (PDF)
Jun 25, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 600MG;60MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2004

No patent or exclusivity listings for this strength.

#002 — 1.2GM;120MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 22, 2004