Details for New Drug Application (NDA): 201464
✉ Email this page to a colleague
NDA 201464 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.
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 201464
| Tradename: | LEVETIRACETAM |
| Applicant: | Pharmadax Inc |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 201464
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 201464
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 201464 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-245 | 75834-245-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-05) |
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 201464 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-245 | 75834-245-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | May 25, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | May 25, 2012 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
