Aminosyn II 8.5% W/ Electrolytes
Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Apr 03, 1986
40 yr 10 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Strength
8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019437
Product number
005
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 019437
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
No other applications share this active ingredient.
View full Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride familyListed 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.
Aminosyn II 8.5% W/ Electrolytes — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
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