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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076974

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NDA 076974 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-nine 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. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 076974

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

Pharmacology for NDA: 076974

Suppliers and Packaging for NDA: 076974

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 076974 ANDA Fresenius Kabi USA, LLC 63323-374 63323-374-20 1 VIAL in 1 BOX (63323-374-20) > 20 mL in 1 VIAL
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 076974 ANDA The Medicines Company 65293-374 65293-374-01 1 VIAL in 1 BOX (65293-374-01) > 20 mL in 1 VIAL (65293-374-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Dec 26, 2006TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Cantor Fitzgerald
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Fuji

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