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FDA Orange Book · active-ingredient family

Amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride

Amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride: 3 brands, 0 generics; first approved May 15, 1984.

Brand onlyHas discontinued products
Generic status & protection

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

Brands (NDA)
3
Generics (ANDA)
0
Listed patents
0
Presentations
3
Originator applications

Brand (NDA) products

Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100MLINJECTABLEINJECTIONDiscontinued
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100MLINJECTABLEINJECTIONDiscontinued
NDA 017789
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100MLINJECTABLEINJECTIONDiscontinued
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
May 15, 1984
42 yr 9 mo ago
Most recent approval
Aug 08, 1984
42 yr 7 mo ago

All 3 applications were approved in 1984.

Brand (NDA) 3100%
Generic (ANDA) 00%

Amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride — 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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