Assyro AI

FDA Orange Book · active-ingredient family

Dextrose; sodium chloride

Dextrose; sodium chloride is approved as 27 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · NDA 016697

27

Brand (NDA)

5

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLDBAXTER HLTHCARENDA 016697APApproved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 017606APApproved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 017799APApproved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 017607APApproved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLDOTSUKA ICU MEDCLNDA 017585APApproved Prior to Jan 1, 1982
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER×16B BRAUNNDA 019631—Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERABBOTTNDA 019482—Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERABBOTTNDA 019486—Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERABBOTTNDA 019484—Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERABBOTTNDA 019483—Oct 04, 1985
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERB BRAUNNDA 018386—Approved Prior to Jan 1, 1982
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERB BRAUNNDA 018229—Approved Prior to Jan 1, 1982
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUNNDA 018047—Approved Prior to Jan 1, 1982
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016696—Approved Prior to Jan 1, 1982
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER×5B BRAUNNDA 018030—Approved Prior to Jan 1, 1982
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHOSPIRANDA 018096—Approved Prior to Jan 1, 1982
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUNNDA 018376—Approved Prior to Jan 1, 1982
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERABBOTTNDA 018055—Approved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERMILESNDA 018399—Approved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERMILESNDA 018501—Approved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERMILESNDA 018400—Approved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERB BRAUNNDA 018026—Approved Prior to Jan 1, 1982
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERMILESNDA 018500—Approved Prior to Jan 1, 1982
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016689APApproved Prior to Jan 1, 1982
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016687APApproved Prior to Jan 1, 1982
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016683APApproved Prior to Jan 1, 1982
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBAXTER HLTHCARENDA 016678APApproved Prior to Jan 1, 1982

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
DEXTROSE 5% AND SODIUM CHLORIDE 0.225%FRESENIUS KABI USAANDA 211221APSep 15, 2020
DEXTROSE 5% AND SODIUM CHLORIDE 0.45%FRESENIUS KABI USAANDA 211276APSep 15, 2020
DEXTROSE 5% AND SODIUM CHLORIDE 0.9%FRESENIUS KABI USAANDA 211211APSep 14, 2020
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 211194APAug 26, 2020
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERFRESENIUS KABI USAANDA 211190APDec 20, 2019

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.

Dextrose; sodium chloride — frequently asked questions

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

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