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Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077545

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NDA 077545 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-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 077545

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

Pharmacology for NDA: 077545

Suppliers and Packaging for NDA: 077545

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL 077545 ANDA West-ward Pharmaceutical Corp 0143-2422 0143-2422-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-2422-01)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL 077545 ANDA West-ward Pharmaceutical Corp 0143-2422 0143-2422-25 3 TABLET in 1 BOX, UNIT-DOSE (0143-2422-25)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 6, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 6, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 24MG BASE
Approval Date:Sep 6, 2007TE:RLD:No


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