Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208458

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NDA 208458 describes LEVETIRACETAM, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Knack, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Actavis Mid Atlantic, Ajenat Pharms, Alembic, Amneal Pharms, Anda Repository, Apotex Inc, Aurobindo Pharma, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Pharm Assoc, Pharmobedient Cnsltg, Quagen, Strides Pharma, Taro, Tolmar, Actavis Elizabeth, Actavis Labs Fl Inc, Adaptis, Aiping Pharm Inc, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax, Rouses Point Pharms, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Accord Hlthcare, Alkem Labs Ltd, China Resources, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mpp Pharma, Mylan, Novax, Orbion Pharms, Oxford Pharms, Rising, Senores Pharms, Torrent Pharms, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical, Caplin, Gland, Hq Spclt Pharma, and Nexus, and is included in one hundred and seven NDAs. It is available from seventy-five suppliers. Additional details are available on the LEVETIRACETAM profile page.

The generic ingredient in LEVETIRACETAM is levetiracetam. There is one drug master file entry for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 208458

Tradename:	LEVETIRACETAM
Applicant:	Baxter Hlthcare Corp
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 208458

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 208458

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	208458	ANDA	Baxter Healthcare Corporation	36000-265	36000-265-05	5 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-05) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01)
LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	208458	ANDA	Baxter Healthcare Corporation	36000-265	36000-265-10	10 VIAL, SINGLE-DOSE in 1 CARTON (36000-265-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-265-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	500MG/5ML (100MG/ML)
Approval Date:	Aug 6, 2026	TE:	AP	RLD:	No

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