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FDA Orange Book · active-ingredient family

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PLENVU · NDA 209381

2

Brand (NDA)

2

Generics (ANDA)

11

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution

ProductApplicantApplicationTEApproved
PLENVURLDSALIXNDA 209381—May 04, 2018
MOVIPREPRLDSALIX PHARMSNDA 021881AAAug 02, 2006

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDTAROANDA 207498—Jun 28, 2024
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDNOVEL LABS INCANDA 090145AAJan 25, 2012

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11529368Mar 09, 2032in 5 yr 10 mo
ProductU-2310
10792306Mar 09, 2032in 5 yr 10 mo
ProductU-2310
10780112Mar 09, 2032in 5 yr 10 mo
Product
10646512Mar 25, 2032in 5 yr 10 mo
Product
9592252Aug 11, 2032in 6 yr 3 mo
ProductU-2310
9326969Sep 10, 2033in 7 yr 4 mo
U-2310
10918723Sep 10, 2033in 7 yr 4 mo
U-2310
12083179Sep 10, 2033in 7 yr 4 mo
ProductU-2310
10016504Sep 10, 2033in 7 yr 4 mo
Product
9707297Sep 10, 2033in 7 yr 4 mo
Product
8999313Sep 10, 2033in 7 yr 4 mo
Product

Ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate — frequently asked questions

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

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