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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRIVARACETAM	BRIVARACETAM	Aurobindo Pharma Limited	57cfb2c3-395d-0892-e063-6294a90a1064	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	SolarisPharmaCorporation	49f726ec-e51b-7516-e063-6294a90ae684	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Exelan Pharmaceuticals, Inc	bf372f42-cfc9-4fcf-8226-3936ba8833d7	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	ScieGen Pharmaceuticals, Inc.	bdbb6756-654c-46f1-a85c-7d5d1a89685a	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Aurobindo Pharma Limited	59817617-956e-4685-81d4-7abe42f4de86	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Aurobindo Pharma Limited	41e218af-048b-4e24-91d2-0b9b262d480c	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
Briviact	BRIVARACETAM	UCB, Inc.	3cf2f439-0e97-443e-8e33-25ecef616f6c	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	AvKARE	5115c5b4-7a23-89f2-e063-6294a90a222a	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Lupin Pharmaceuticals, Inc.	260468dd-a604-488a-a47b-b6d82edcca37	2026-02-28	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Apotex Corp.	1915620d-4f37-56c2-437e-8362bb462d07	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
BRIVARACETAM	BRIVARACETAM	Micro Labs Limited	c054a1c9-2aa7-473b-a04b-622596f36c95	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: BRIVARACETAM generic name: BRIVARACETAM
Brivaracetam Oral Solution	BRIVARACETAM	Ascend Laboratories, LLC	c4ee9b82-1067-4efc-b3d9-f24eb0c461d5	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Novadoz Pharmaceuticals LLC	2c6af271-3222-4602-98a6-14754f0a29ba	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	Hainan Poly Pharm. Co., Ltd.	3ea51292-fe03-46f5-9d9b-36986f5b7224	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Zhejiang Poly Pharm. Co., Ltd.	aef3ee92-e2a6-4135-94b2-b893f893d5f2	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM INJECTION	PAI Holdings, LLC dba PAI Pharma	5bc0f4c0-8b31-4622-849f-d902be93788b	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam
brivaracetam	BRIVARACETAM	Novadoz Pharmaceuticals LLC	dca92c5b-78a8-4ee1-9f06-18320ae2a2e8	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: brivaracetam generic name: BRIVARACETAM
Brivaracetam	BRIVARACETAM	PAI Holdings, LLC dba PAI Pharma	57627ea9-3b14-4428-ad95-6ea25ecaef31	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Brivaracetam generic name: BRIVARACETAM
brivaracetam	BRIVARACETAM	Zydus Lifesciences Limited	67c4db20-ba4d-4640-9e9c-6949b85429e3	2026-01-27		Name fallback brand name: brivaracetam generic name: BRIVARACETAM
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