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Serving leading biopharmaceutical companies globally:

Covington
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078152

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NDA 078152 describes ONDANSETRON, which is a drug marketed by Sun Pharm Inds Ltd, Chartwell Molecules, Teva, Nesher Pharms, Mylan, Sandoz, Glenmark Generics, Sun Pharm Inds, Aurobindo Pharma, Barr, Mylan Labs Ltd, Apotex, Taro, Qilu Pharm Co Ltd, Pliva Hrvatska Doo, Lannett, Emcure Pharms, Gland Pharma Ltd, Sandoz Inc, Luitpold, Hospira, Silarx, Hikma Intl Pharms, Accord Hlthcare, Sun Pharm Inds (in), Natco Pharma Ltd, West-ward Pharms Int, Ipca Labs Ltd, Apotex Inc, Fresenius Kabi Usa, Wockhardt, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, Baxter Hlthcare Corp, Aurobindo Pharma Ltd, Taro Pharms Ireland, and Emcure Pharms Ltd, and is included in seventy-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the ONDANSETRON profile page.

The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 078152

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078152

Suppliers and Packaging for NDA: 078152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL 078152 ANDA Stat Rx USA 16590-545 16590-545-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (16590-545-30)
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL 078152 ANDA Aidarex Pharmaceuticals LLC 33261-747 33261-747-01 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (33261-747-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Jun 27, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Jun 27, 2007TE:ABRLD:No


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Mallinckrodt
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Dow
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