Last Updated: June 6, 2026

Details for New Drug Application (NDA): 209474

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NDA 209474 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 209474

Tradename:	LEVETIRACETAM
Applicant:	Prinston Inc
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 209474

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 209474

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	209474	ANDA	Solco Healthcare US, LLC	43547-454	43547-454-10	10 VIAL, SINGLE-DOSE in 1 CARTON (43547-454-10) / 5 mL in 1 VIAL, SINGLE-DOSE (43547-454-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	500MG/5ML (100MG/ML)
Approval Date:	Mar 28, 2022	TE:	AP	RLD:	No

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