Guaifenesin
Guaifenesin: 1 brand, 9 generics; first approved Jul 12, 2002; generic available.
Generic available: 9 ANDA applications approved.
Brand (NDA) products
- RECKITT BENCKISERNDA 02128220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC —
Generic (ANDA) products (9)
- GUAIFENESINMARKSANS PHARMAANDA 21778020232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINDR REDDYSANDA 21593220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINPERRIGO R AND DANDA 07891220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINGRANULESANDA 21342020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINAUROBINDO PHARMAANDA 21045320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINOHM LABS INCANDA 20925420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINAMNEAL PHARMSANDA 20734220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINGUARDIAN DRUGANDA 20921520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET, EXTENDED RELEASE ORAL OTC — 1.2GM TABLET, EXTENDED RELEASE ORAL OTC — - GUAIFENESINACTAVIS LABS FLANDA 0910092015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, EXTENDED RELEASE ORAL OTC —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2002–2023 across 10 FDA applications.
Guaifenesin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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