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FDA Orange Book · active-ingredient family

Hydroxystilbamidine isethionate

Hydroxystilbamidine isethionate: 1 brand, 0 generics.

Brand onlyHas discontinued products
Generic status & protection

No listed patents or exclusivity: brand product(s) only.

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

Brand (NDA) products

Originator applications
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  • HYDROXYSTILBAMIDINE ISETHIONATE
    NDA 009166-
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    225MG/AMPINJECTABLEINJECTIONDiscontinued-

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.

Hydroxystilbamidine isethionate: 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

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