DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078522
The generic ingredient in GRANISETRON HYDROCHLORIDE is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.
Summary for 078522
Tradename: | GRANISETRON HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | granisetron hydrochloride |
Patents: | 0 |
Therapeutic Class: | Antiemetics |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078522
Mechanism of Action | Serotonin 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 | N | 63323-317-01 |
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: | Dec 31, 2007 | TE: | AP | RLD: | No |
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