NDC 52652-9001

Eprontia

Topiramate

Eprontia is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Azurity Pharmaceuticals, Inc.. The primary component is Topiramate.

Product ID52652-9001_29a0a3e7-a450-4fb1-95af-e4ff74ebe3e5
NDC52652-9001
Product TypeHuman Prescription Drug
Proprietary NameEprontia
Generic NameTopiramate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2021-12-06
Marketing CategoryNDA /
Application NumberNDA214679
Labeler NameAzurity Pharmaceuticals, Inc.
Substance NameTOPIRAMATE
Active Ingredient Strength25 mg/mL
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52652-9001-1

473 mL in 1 BOTTLE (52652-9001-1)
Marketing Start Date2021-12-06
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Eprontia" or generic name "Topiramate"

NDCBrand NameGeneric Name
0245-1071QUDEXYTopiramate
0245-1072QUDEXYTopiramate
0245-1073QUDEXYTopiramate
0245-1074QUDEXYTopiramate
0245-1075QUDEXYTopiramate
0093-7335TopiramateTopiramate
0093-7336TopiramateTopiramate
0615-7562TopiramateTopiramate
0615-7563TopiramateTopiramate
0615-7564TopiramateTopiramate
0615-7565TopiramateTopiramate
0615-8138TopiramateTopiramate
0615-8139TopiramateTopiramate

Trademark Results [Eprontia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPRONTIA
EPRONTIA
90690878 not registered Live/Pending
Azurity Pharmaceuticals, Inc.
2021-05-05
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.