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FDA Orange Book · active-ingredient family

Calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate

Calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate is approved as 7 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER · NDA 020183

7

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERRLD×4VANTIVE US HLTHCARENDA 020183ATDec 04, 1992
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINERRLD×3VANTIVE US HLTHCARENDA 020163ATDec 04, 1992
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINERRLD×3FRESENIUS MEDCLNDA 020171ATAug 19, 1992
DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINERRLD×15VANTIVE US HLTHCARENDA 017512ATJan 10, 1989
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINERRLD×6FRESENIUS MEDCLNDA 018883—Nov 30, 1984
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER×6B BRAUNNDA 018460—Jan 29, 1986
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER×8FRESENIUS MEDCLNDA 018379—Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER×4FRESENIUSANDA 020374—Jun 13, 1994

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; magnesium chloride; sodium chloride; sodium lactate — frequently asked questions

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

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