Last Updated: June 9, 2026

Details for New Drug Application (NDA): 078976

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NDA 078976 describes LEVETIRACETAM, which is a drug marketed by Am Regent, 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, Orbion Pharms, Oxford Pharms, Rising, Senores Pharms, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical, Baxter Hlthcare Corp, Caplin, Gland, Hq Spclt Pharma, and Nexus, and is included in one hundred and five 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 are thirty-five drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 078976

Tradename:	LEVETIRACETAM
Applicant:	Actavis Mid Atlantic
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 078976

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 078976

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	078976	ANDA	Actavis Pharma, Inc.	0472-0235	0472-0235-16	473 mL in 1 BOTTLE, PLASTIC (0472-0235-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Jan 15, 2009	TE:	AA	RLD:	No

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