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FDA Orange Book · active-ingredient family

Magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate

Magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate is approved as 8 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER · NDA 017378

8

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINERRLD×2BAXTER HLTHCARENDA 017378—Approved Prior to Jan 1, 1982
ISOLYTE S IN PLASTIC CONTAINERB BRAUNNDA 019711—Sep 29, 1989
SYNOVALYTE IN PLASTIC CONTAINERBAXTER HLTHCARENDA 019326—Jan 25, 1985
PHYSIOLYTE IN PLASTIC CONTAINERB BRAUNNDA 019024—Jun 08, 1984
PHYSIOSOL IN PLASTIC CONTAINEROTSUKA ICU MEDCLNDA 017637—Jul 08, 1982
ISOLYTE S IN PLASTIC CONTAINERB BRAUNNDA 018252—Approved Prior to Jan 1, 1982
NORMOSOL-R IN PLASTIC CONTAINEROTSUKA ICU MEDCLNDA 017586—Approved Prior to Jan 1, 1982
PHYSIOSOL IN PLASTIC CONTAINER×2HOSPIRA INCNDA 018406—Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5FRESENIUS KABI USAANDA 215370—Jun 29, 2022
MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4FRESENIUS KABI USAANDA 215371APJun 08, 2022

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.

Magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate — frequently asked questions

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

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