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FDA Orange Book · active-ingredient family

Calcium chloride; dextrose; sodium chloride; sodium lactate

Calcium chloride; dextrose; sodium chloride; sodium lactate: 1 brand, 0 generics; first approved Mar 26, 1986.

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
3

Brand (NDA) products

Originator applications
  • NDA 01939519863 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    25.7MG/100ML;1.5GM/100ML;538MG/100ML;448MG/100MLSOLUTIONINTRAPERITONEALDiscontinued
    25.7MG/100ML;2.5GM/100ML;538MG/100ML;448MG/100MLSOLUTIONINTRAPERITONEALDiscontinued
    25.7MG/100ML;4.25GM/100ML;538MG/100ML;448MG/100MLSOLUTIONINTRAPERITONEALDiscontinued

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
40 yr 11 mo ago
Most recent approval
40 yr 11 mo ago

All 1 application were approved in 1986.

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

Calcium chloride; dextrose; sodium chloride; sodium lactate: 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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