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Last Updated: November 2, 2024

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for naproxen sodium; pseudoephedrine hydrochloride and what is the scope of patent protection?

Naproxen sodium; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Bayer, Aurobindo Pharma, Dr Reddys Labs Inc, and Perrigo, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

See all NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211360-001 Jun 1, 2022 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Inc NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077381-001 Sep 27, 2006 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer ALEVE-D SINUS & COLD naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021076-001 Nov 29, 1999 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Perrigo NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076518-001 Mar 17, 2004 OTC No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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