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Last Updated: September 21, 2020

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Details for New Drug Application (NDA): 077324

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NDA 077324 describes LEVETIRACETAM, which is a drug marketed by Akorn, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Aci Healthcare Ltd, Actavis Mid Atlantic, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Dexcel Pharma, Eci Pharms Llc, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Accord Hlthcare, Aurobindo Pharma, Breckenridge Pharm, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Viwit Pharm, Vkt Pharma, Watson Labs Inc, Wockhardt, Zhejiang Jingxin, Zydus Pharms Usa Inc, Gland Pharma Ltd, Hq Speciality Pharma, and Nexus Pharms, and is included in eighty-nine NDAs. It is available from seventy-three 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 suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 077324
Tradename:LEVETIRACETAM
Applicant:Fosun Pharma
Ingredient:levetiracetam
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Jan 15, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Jan 15, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG
Approval Date:Jan 15, 2009TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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