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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078522

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NDA 078522 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Sandoz Inc, West-ward Pharms Int, Taro Pharm, Akorn Inc, Barr, Fresenius Kabi Usa, Mylan, Hikma Farmaceutica, Sagent Strides, Sagent Agila, Cipla Ltd, Aurobindo Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Mylan Labs Ltd, Epic Pharma Llc, Bionpharma Inc, Teva Pharms Usa, Wockhardt Usa, Natco Pharma, Luitpold, Orchid Hlthcare, Teva Pharms, and Claris, and is included in forty-four NDAs. It is available from eighteen suppliers. Additional details are available on the GRANISETRON HYDROCHLORIDE profile page.

The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Summary for NDA: 078522

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

Pharmacology for NDA: 078522

Mechanism of ActionSerotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 078522

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GRANISETRON HYDROCHLORIDE
granisetron hydrochloride
 INJECTABLE;INJECTION 078522 ANDA Fresenius Kabi USA, LLC 63323-317 63323-317-01 10 VIAL, SINGLE-USE in 1 TRAY (63323-317-01) > 1 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Approval Date:Dec 31, 2007TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
Novartis
Julphar
Accenture
Boehringer Ingelheim
Dow
US Department of Justice
Merck
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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