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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078976

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NDA 078976 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, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Accord Hlthcare, Acic Pharms, Aurobindo Pharma, Breckenridge Pharm, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Vintage Pharms, Watson Labs Inc, Wockhardt, Zydus Pharms Usa Inc, Gland Pharma Ltd, and Hq Speciality Pharma, and is included in eighty-seven NDAs. It is available from seventy-one 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-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 078976
Applicant:Actavis Mid Atlantic
Formulation / Manufacturing:see details
Pharmacology for NDA: 078976
Suppliers and Packaging for NDA: 078976
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam SOLUTION;ORAL 078976 ANDA Actavis Pharma, Inc. 0472-0235 0472-0235-16 473 mL in 1 BOTTLE, PLASTIC (0472-0235-16)
LEVETIRACETAM levetiracetam SOLUTION;ORAL 078976 ANDA VistaPharm, Inc. 66689-028 66689-028-50 5 TRAY in 1 CASE (66689-028-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-028-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Jan 15, 2009TE:AARLD:No

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