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Serving 500+ biopharmaceutical companies globally:

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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076781

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NDA 076781 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Chartwell Molecules, Mylan Labs Ltd, 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, 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, Emcure Pharms Ltd, and Sun Pharm Inds Ltd, and is included in sixty-eight 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: 076781

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

Pharmacology for NDA: 076781

Suppliers and Packaging for NDA: 076781

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 076781 ANDA West-Ward Pharmaceuticals Corp 0143-9890 0143-9890-01 20 mL in 1 VIAL, MULTI-DOSE (0143-9890-01)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION 076781 ANDA West-Ward Pharmaceuticals Corp 0143-9890 0143-9890-10 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9890-10) > 20 mL in 1 VIAL, MULTI-DOSE (0143-9890-01)

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:

UBS
Queensland Health
Moodys
US Army
Medtronic
Cipla
AstraZeneca
Cerilliant
Novartis
Deloitte

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