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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091342

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NDA 091342 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Chartwell Molecules, Apotex, Taro, Qilu Pharm Co Ltd, Pliva Hrvatska Doo, Lannett, Sandoz, Emcure Pharms, Gland Pharma Ltd, Sandoz Inc, Mylan, Glenmark Generics, Luitpold, Aurobindo Pharma, Hospira, Silarx, Hikma Intl Pharms, Accord Hlthcare, Sun Pharm Inds (in), Natco Pharma Ltd, Teva, Mylan Labs Ltd, West-ward Pharms Int, Ipca Labs Ltd, Apotex Inc, Fresenius Kabi Usa, Wockhardt, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, Claris, Aurobindo Pharma Ltd, Taro Pharms Ireland, Emcure Pharms Ltd, and Sun Pharm Inds Ltd, and is included in sixty-seven NDAs. It is available from sixty-eight suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

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

Summary for NDA: 091342

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

Pharmacology for NDA: 091342

Suppliers and Packaging for NDA: 091342

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
SOLUTION;ORAL 091342 ANDA Silarx Pharmaceuticals, Inc. 54838-555 54838-555-50 50 mL in 1 BOTTLE, PLASTIC (54838-555-50)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
SOLUTION;ORAL 091342 ANDA NuCare Pharmaceuticals, Inc. 68071-3275 68071-3275-5 50 mL in 1 BOX (68071-3275-5)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 4MG BASE/5ML
Approval Date:Jan 27, 2011TE:AARLD:No


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