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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 078858


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NDA 078858 describes LEVETIRACETAM, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Beowulf Asset, 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, ACI, Actavis Mid Atlantic, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Belcher, 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, Anchen Pharms, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Dexcel, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Pharmadax Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Accord Hlthcare, Alkem Labs Ltd, Dr Reddys Labs Ltd, Fosun Pharma, Granules, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Rising, Secan Pharms, Stallion Labs, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, Gland Pharma Ltd, Hq Spclt Pharma, and Nexus, and is included in one hundred NDAs. It is available from seventy-six 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-five suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 078858
Tradename:LEVETIRACETAM
Applicant:Torrent Pharms
Ingredient:levetiracetam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078858
Suppliers and Packaging for NDA: 078858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam TABLET;ORAL 078858 ANDA Torrent Pharmaceuticals Limited 13668-014 13668-014-05 500 TABLET in 1 BOTTLE (13668-014-05)
LEVETIRACETAM levetiracetam TABLET;ORAL 078858 ANDA Torrent Pharmaceuticals Limited 13668-014 13668-014-12 120 TABLET in 1 BOTTLE (13668-014-12)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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