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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205130


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NDA 205130 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, 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, Adaptis, Aiping Pharm Inc, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Endo Operations, 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, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Rising, Secan Pharms, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical Inc, Baxter Hlthcare Corp, Gland Pharma Ltd, Hq Spclt Pharma, and Nexus, and is included in one hundred and two 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-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 205130
Tradename:LEVETIRACETAM
Applicant:Sciegen Pharms Inc
Ingredient:levetiracetam
Patents:0
Pharmacology for NDA: 205130
Suppliers and Packaging for NDA: 205130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 205130 ANDA ScieGen Pharmaceuticals, Inc 50228-189 50228-189-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05)
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 205130 ANDA ScieGen Pharmaceuticals, Inc 50228-189 50228-189-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Nov 27, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Nov 27, 2020TE:ABRLD:No

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