Guanabenz acetate
Guanabenz acetate: 1 brand, 4 generics; first approved Sep 07, 1982; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- WYETH AYERSTNDA 01858719823 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - EQ 16MG BASE TABLET ORAL Discontinued -
Generic (ANDA) products (4)
- GUANABENZ ACETATECHARTWELL RXANDA 07451719982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - - GUANABENZ ACETATEANI PHARMSANDA 07414919952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - - GUANABENZ ACETATEANI PHARMSANDA 07426719942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued - - GUANABENZ ACETATEWATSON LABSANDA 07402519942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET ORAL Discontinued - EQ 8MG BASE TABLET ORAL Discontinued -
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 1982–1998 across 5 FDA applications.
Guanabenz acetate: 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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