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Details for New Drug Application (NDA): 078197

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NDA 078197 describes GRANISETRON HYDROCHLORIDE, which is a drug marketed by Sandoz Inc, Eurohlth Intl Sarl, Taro, Akorn Inc, Barr, Fresenius Kabi Usa, Mylan, Hikma Farmaceutica, Sandoz, Sagent Strides, Sagent Agila, Cipla Ltd, Aurobindo Pharma Ltd, Roxane, Apotex Inc, Dr Reddys Labs Ltd, Corepharma, Bionpharma Inc, Teva Pharms Usa, Wockhardt Usa, Natco Pharma, Luitpold, Orchid Hlthcare, Teva Pharms, and Claris, and is included in forty-two 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: 078197

granisetron hydrochloride
Therapeutic Class:Antiemetics

Summary for product number 001

Approval Date:Dec 31, 2007TE:RLD:No

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