Details for New Drug Application (NDA): 078096
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NDA 078096 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 078096
| Tradename: | GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | granisetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078096
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078096
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE | granisetron hydrochloride | INJECTABLE;INJECTION | 078096 | ANDA | Fresenius Kabi USA, LLC | 63323-318 | 63323-318-01 | 1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| 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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