Details for New Drug Application (NDA): 090876
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NDA 090876 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, 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, Anda Repository, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Dexcel, 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, 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, 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-five 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-six suppliers are listed for this compound. 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-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090876
| Tradename: | LEVETIRACETAM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 090876
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090876 | ANDA | Fresenius Kabi USA, LLC | 63323-400 | 63323-400-05 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01) |
| LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090876 | ANDA | Fresenius Kabi USA, LLC | 63323-400 | 63323-400-44 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/5ML (100MG/ML) | ||||
| Approval Date: | Aug 13, 2015 | TE: | AP | RLD: | No | ||||
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