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FDA Orange Book · active-ingredient family

Manganese sulfate

Manganese sulfate: 1 brand, 0 generics; first approved May 05, 1987.

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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  • MANGANESE SULFATERLD
    NDA 0192281987
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 0.1MG MANGANESE/MLINJECTABLEINJECTIONDiscontinued-

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
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First approval
40 yr 1 mo ago
Most recent approval
40 yr 1 mo ago

All 1 application were approved in 1987.

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

Manganese sulfate: 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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