FDA Orange Book · active-ingredient family
Guanfacine hydrochloride
Guanfacine hydrochloride: 2 brands, 25 generics; first approved Oct 27, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
25
Listed patents
0
Presentations
83
Brand (NDA) products
Originator applications
- INTUNIVRLDTAKEDA PHARMS USANDA 02203720094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - TENEXRLDPROMIUS PHARMANDA 01903219863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - EQ 2MG BASE TABLET ORAL Discontinued - EQ 3MG BASE TABLET ORAL Discontinued -
Generic (ANDA) products (25)
Abbreviated applications
- GUANFACINE HYDROCHLORIDEASCENT PHARMS INCANDA 22067520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDERUBICON RESEARCHANDA 21968920254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEUNICHEMANDA 21903320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEFOSUN WANBANGANDA 21763820244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEXIROMEDANDA 21832620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDERUBICON RESEARCHANDA 21676220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEI 3 PHARMSANDA 21682820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEALEMBICANDA 21726920234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEAJANTA PHARMA LTDANDA 21729320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEAIPING PHARM INCANDA 21639920222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEUNICHEMANDA 21468920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEYICHANG HUMANWELLANDA 21342820204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEAPOTEXANDA 20543020184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDESUN PHARMANDA 20568920174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - - GUANFACINE HYDROCHLORIDEIMPAX LABS INCANDA 20223820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - - GUANFACINE HYDROCHLORIDESANDOZANDA 20256820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEPHARMOBEDIENTANDA 20257820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued - - GUANFACINE HYDROCHLORIDETEVA PHARMS USAANDA 20138220154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDETWI PHARMSANDA 20140820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 20088120124 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 2MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 3MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - GUANFACINE HYDROCHLORIDEAMNEAL PHARMANDA 07510919982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEWATSON LABSANDA 07476219972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Discontinued - EQ 2MG BASE TABLET ORAL Discontinued - - GUANFACINE HYDROCHLORIDEEPIC PHARMA LLCANDA 07467319972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEAUROBINDO PHARMA USAANDA 07479619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB - GUANFACINE HYDROCHLORIDEWATSON LABSANDA 07414519952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 2MG BASE TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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
FDA approval span
First approval
40 yr 7 mo ago
Most recent approval
7 mo ago
Approvals span 1986–2026 across 27 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2593%
Guanfacine hydrochloride: 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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