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FDA Approval

Eprontia

CompanyAzurity Pharmaceuticals, Inc. (DUNS: 117505635)

Effective Date

May 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Topiramate(25 mg in 1 mL)

Products (1)

Eprontia

NDC Product Code

52652-9001

Application Number

NDA214679

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 11, 2023

Ingredients

TopiramateActive

Code: 0H73WJJ391Class: ACTIBQuantity: 25 mg in 1 mL

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

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