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FDA Orange Book · active-ingredient family

Calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate

Calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BSS PLUS · NDA 018469

2

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
BSS PLUSRLDALCONNDA 018469Approved Prior to Jan 1, 1982
METHOTREXATE SODIUMEPIC PHARMA LLCNDA 020079Feb 26, 1999

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.

Calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate — 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.