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FDA Orange Book · active-ingredient family

Dapiprazole hydrochloride

Dapiprazole hydrochloride: 1 brand, 1 generic; first approved Dec 31, 1990; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 1 ANDA application approved.

Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2

Brand (NDA) products

Originator applications
  • DAPIPRAZOLE HYDROCHLORIDERLD
    NDA 0198491990
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.5%SOLUTION/DROPSOPHTHALMICDiscontinued—

Generic (ANDA) products (1)

Abbreviated applications
  • DAPIPRAZOLE HYDROCHLORIDE
    ANDA 2049022019
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    0.5%SOLUTION/DROPSOPHTHALMICDiscontinued—

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 2 mo ago
Most recent approval
7 yr 4 mo ago

Approvals span 1990–2019 across 2 FDA applications.

Brand (NDA) 150%
Generic (ANDA) 150%

Dapiprazole 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.

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