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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 090876

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NDA 090876 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, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Actavis Mid Atlantic, 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, Adaptis, Aiping Pharm Inc, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, 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, 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 three NDAs. It is available from seventy-two 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-four suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

Summary for 090876

Tradename:	LEVETIRACETAM
Applicant:	Fresenius Kabi Usa
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 090876

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 090876

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	090876	ANDA	Fresenius Kabi USA, LLC	63323-400	63323-400-05	10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01)
LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	090876	ANDA	Fresenius Kabi USA, LLC	63323-400	63323-400-44	10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	500MG/5ML (100MG/ML)
Approval Date:	Aug 13, 2015	TE:	AP	RLD:	No

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