FDA Orange Book · active-ingredient family
Doxazosin mesylate
Doxazosin mesylate: 2 brands, 19 generics; first approved Nov 02, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
19
Listed patents
0
Presentations
82
Brand (NDA) products
Originator applications
- CARDURA XLRLDVIATRISNDA 02126920052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 8MG BASE TABLET, EXTENDED RELEASE ORAL Rx — - VIATRISNDA 01966819904 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (19)
Abbreviated applications
- DOXAZOSIN MESYLATEUNICHEMANDA 21232920244 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATERISINGANDA 21272720224 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATESOMERSET THERAPS LLCANDA 20901320184 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATEHERITAGE PHARMAANDA 20521020184 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATEZYDUS PHARMSANDA 20871920174 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATEACCORD HLTHCAREANDA 20282420144 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATESTRIDES PHARMA INTLANDA 07616120044 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEPLIVAANDA 07575020014 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATETEVAANDA 07535320014 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEAUROBINDO PHARMA USAANDA 07550920004 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATEACTAVIS ELIZABETHANDA 07557420004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEANI PHARMSANDA 07543220004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEAPOTEXANDA 07558020004 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATECHARTWELL RXANDA 07564620004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEGENPHARMANDA 07546620004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATEIVAX SUB TEVA PHARMSANDA 07545320004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATENESHER PHARMSANDA 07560920004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued — - DOXAZOSIN MESYLATETEVAANDA 07553620004 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 EQ 4MG BASE TABLET ORAL Rx AB EQ 8MG BASE TABLET ORAL Rx AB - DOXAZOSIN MESYLATEWATSON LABS INCANDA 07542620004 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 4MG BASE TABLET ORAL Discontinued — EQ 8MG BASE TABLET ORAL Discontinued —
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
36 yr 4 mo ago
Most recent approval
2 yr 8 mo ago
Approvals span 1990–2024 across 21 FDA applications.
Brand (NDA) 210%
Generic (ANDA) 1990%
Doxazosin mesylate: 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.
