Details for New Drug Application (NDA): 078863
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NDA 078863 describes GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Bionpharma, Dr Reddys, and Fresenius Kabi Usa, and is included in three NDAs. It is available from one supplier. Additional details are available on the GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is granisetron hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
The generic ingredient in GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE is granisetron hydrochloride. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078863
| Tradename: | GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Bionpharma |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | ||||
| Approval Date: | Jun 30, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Jun 30, 2008 | TE: | AP | RLD: | No | ||||
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