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Last Updated: April 17, 2021

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Details for New Drug Application (NDA): 090981

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NDA 090981 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, Alembic Labs, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Florida, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharma Life, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, 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 ninety NDAs. It is available from seventy-two 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. Seventy-nine suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090981
Tradename:LEVETIRACETAM
Applicant:Hikma Farmaceutica
Ingredient:levetiracetam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090981
Suppliers and Packaging for NDA: 090981
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 090981 ANDA Hikma Pharmaceuticals USA Inc. 0143-9574 0143-9574-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)
LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 090981 ANDA Hikma Pharmaceuticals USA Inc. 0143-9574 0143-9574-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength500MG/5ML (100MG/ML)
Approval Date:Oct 13, 2011TE:APRLD:No

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