Application 219583

Type: ANDA
Sponsor: SHANDONG NEW TIME PHARMACEUTICAL CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRIVARACETAM	BRIVARACETAM	TABLET	10MG	No	No
002	BRIVARACETAM	BRIVARACETAM	TABLET	25MG	No	No
003	BRIVARACETAM	BRIVARACETAM	TABLET	50MG	No	No
004	BRIVARACETAM	BRIVARACETAM	TABLET	75MG	No	No
005	BRIVARACETAM	BRIVARACETAM	TABLET	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
brivaracetam	BRIVARACETAM	Zydus Pharmaceuticals USA Inc.	d54ca946-2ddf-4a67-87c9-20a814bfd2dc	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.