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FDA Orange Book · active-ingredient family

Prazosin hydrochloride

Prazosin hydrochloride: 2 brands, 23 generics; first approved Sep 12, 1988; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 23 ANDA applications approved.

Brands (NDA)
2
Generics (ANDA)
23
Listed patents
0
Presentations
50
Originator applications

Brand (NDA) products

NDA 0174423 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALRxAB
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
NDA 01977519922 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2.5MGTABLET, EXTENDED RELEASEORALDiscontinued
5MGTABLET, EXTENDED RELEASEORALDiscontinued
Abbreviated applications

Generic (ANDA) products (23)

ANDA 21672720243 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21408320243 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALDiscontinued
EQ 2MG BASECAPSULEORALDiscontinued
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 21305220233 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21726820233 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21569720223 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21340620223 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21460820213 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 21097120183 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 5MG BASECAPSULEORALRxAB
ANDA 0727821989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALDiscontinued
ANDA 0727831989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 2MG BASECAPSULEORALDiscontinued
ANDA 0727841989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 07257719893 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 2MG BASECAPSULEORALDiscontinued
EQ 1MG BASECAPSULEORALDiscontinued
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 0727051989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALDiscontinued
ANDA 0727061989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 2MG BASECAPSULEORALDiscontinued
ANDA 0727071989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 07257519893 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
EQ 1MG BASECAPSULEORALRxAB
ANDA 0729911989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALDiscontinued
ANDA 0729211989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 2MG BASECAPSULEORALDiscontinued
ANDA 0729921989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 0723521989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 1MG BASECAPSULEORALDiscontinued
ANDA 0723331989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 2MG BASECAPSULEORALDiscontinued
ANDA 0726091989
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALDiscontinued
ANDA 07174519883 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 5MG BASECAPSULEORALRxAB
EQ 1MG BASECAPSULEORALRxAB
EQ 2MG BASECAPSULEORALRxAB
Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval
Sep 12, 1988
38 yr 5 mo ago
Most recent approval
Sep 17, 2024
1 yr 10 mo ago

Approvals span 1988–2024 across 25 FDA applications.

Brand (NDA) 28%
Generic (ANDA) 2392%

Prazosin 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

Agent CTA Background

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