Details for New Drug Application (NDA): 204511
✉ Email this page to a colleague
NDA 204511 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, Ajenat Pharms, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma, 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, China Resources, Dr Reddys Labs Ltd, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mylan, Nostrum Labs Inc, Orbion Pharms, Oxford Pharms, Rising, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical Inc, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hq Spclt Pharma, and Nexus, and is included in one hundred and three NDAs. It is available from seventy-seven 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 204511
| Tradename: | LEVETIRACETAM |
| Applicant: | Anda Repository |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 204511
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 204511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204511 | ANDA | IntelliPharmaCeutics Corp. | 35208-031 | 35208-031-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-031-10) |
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204511 | ANDA | IntelliPharmaCeutics Corp. | 35208-031 | 35208-031-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35208-031-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Feb 23, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | Feb 23, 2016 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
