Details for New Drug Application (NDA): 203468
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NDA 203468 describes LEVETIRACETAM, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Knack, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Actavis Mid Atlantic, Ajenat Pharms, Alembic, Amneal Pharms, Anda Repository, 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, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax, Rouses Point Pharms, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Accord Hlthcare, Alkem Labs Ltd, China Resources, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mpp Pharma, Mylan, Novax, Orbion Pharms, Oxford Pharms, Rising, Senores Pharms, Torrent Pharms, Watson Labs Inc, Zhejiang Jingxin, Zydus Pharms Usa Inc, B Braun Medical, Caplin, Gland, Hq Spclt Pharma, and Nexus, and is included in one hundred and seven 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 is one drug master file entry 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 is one drug master file entry for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 203468
| Tradename: | LEVETIRACETAM |
| Applicant: | Prinston Inc |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 203468
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 203468
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 203468 | ANDA | Solco healthcare U.S., LLC | 43547-345 | 43547-345-06 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-345-06) |
| LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 203468 | ANDA | Solco healthcare U.S., LLC | 43547-345 | 43547-345-50 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-345-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | May 21, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | May 21, 2015 | TE: | AB | RLD: | No | ||||
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