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FDA Orange Book · active-ingredient family

Succimer

Succimer: 1 brand, 0 generics; first approved Jan 30, 1991.

Brand only
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
  • CHEMETRLDRS
    NDA 0199981991
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    100MGCAPSULEORALRx—

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 3 mo ago
Most recent approval
36 yr 3 mo ago

All 1 application were approved in 1991.

Brand (NDA) 1100%
Generic (ANDA) 00%

Succimer: 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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