Last Updated: November 9, 2026

Details for New Drug Application (NDA): 078960

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NDA 078960 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, Adaptis, Ajenat Pharms, Alembic, Amneal Pharms, 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, Aiping Pharm Inc, Alicora, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Ph Health, Rouses Point Pharms, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Yabao Pharm, Accord Hlthcare, Alkem Labs Ltd, China Resources, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mpp Pharma, Mylan, Novax, Orbion Pharms, Oxford Pharms, Pharmazone, Rising, 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 078960

Tradename:	LEVETIRACETAM
Applicant:	Taro
Ingredient:	levetiracetam
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Feb 1, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Feb 1, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Feb 1, 2010	TE:		RLD:	No

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