Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203052

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NDA 203052 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 203052

Tradename:	LEVETIRACETAM
Applicant:	Hetero Labs Ltd Iii
Ingredient:	levetiracetam
Patents:	0

Pharmacology for NDA: 203052

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 203052

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	203052	ANDA	Atlantic Biologicals Corp.	17856-0574	17856-0574-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0574-2)
LEVETIRACETAM	levetiracetam	SOLUTION;ORAL	203052	ANDA	Atlantic Biologicals Corp.	17856-0574	17856-0574-3	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-3) / 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/ML
Approval Date:	Feb 28, 2013	TE:	AA	RLD:	No

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