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Last Updated: May 27, 2022

Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details


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Recent Clinical Trials for guaifenesin; pseudoephedrine hydrochloride

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1
Reckitt Benckiser Inc.Phase 4
Reckitt Benckiser LLCPhase 4

See all guaifenesin; pseudoephedrine hydrochloride clinical trials

Pharmacology for guaifenesin; pseudoephedrine hydrochloride
Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MUCINEX D Extended-release Tablets guaifenesin; pseudoephedrine hydrochloride 600 mg/60 mg and 1200 mg/120 mg 021585 1 2008-12-29

US Patents and Regulatory Information for guaifenesin; 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 Ltd GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 213203-002 Mar 25, 2020 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212542-002 Apr 28, 2020 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
L Perrigo Co GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214407-002 Feb 1, 2022 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 OTC Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Labs Fl GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 091071-002 May 27, 2015 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for guaifenesin; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-002 Jun 22, 2004 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 See Plans and Pricing See Plans and Pricing
Rb Hlth MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585-001 Jun 22, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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