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FDA Orange Book · active-ingredient family

Amino acids; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride

Amino acids; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

1

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER×2ABBOTTNDA 019564Dec 16, 1986

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.

Amino acids; dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.