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Details for New Drug Application (NDA): 076930

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NDA 076930 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Par Pharm, Apotex, Taro, Qilu Pharm Co Ltd, Pliva Hrvatska Doo, Lannett, Sandoz, Emcure Pharms, Gland Pharma Ltd, Mylan, Glenmark Generics, Luitpold, Aurobindo Pharma, Hospira, Silarx, Hikma Intl Pharms, Accord Hlthcare, Sun Pharm Inds (in), Natco Pharma Ltd, Teva, Mylan Labs Ltd, Roxane, Ipca Labs Ltd, Eurohlth Intl Sarl, 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. Seventy suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 076930

Tradename:
ONDANSETRON HYDROCHLORIDE
Applicant:
Mylan
Ingredient:
ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076930

Suppliers and Packaging for NDA: 076930

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL 076930 ANDA Mylan Pharmaceuticals Inc. 0378-0315 0378-0315-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-93)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL 076930 ANDA Mylan Pharmaceuticals Inc. 0378-0344 0378-0344-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0344-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 24MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No


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