Details for New Drug Application (NDA): 205648
✉ Email this page to a colleague
The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 205648
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Qilu Pharm Hainan |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205648
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 205648
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 205648 | ANDA | Apotex Corp. | 60505-6193 | 60505-6193-1 | 1 VIAL in 1 CARTON (60505-6193-1) / 5 mL in 1 VIAL |
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 205648 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0514 | 67184-0514-1 | 1 VIAL in 1 CARTON (67184-0514-1) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Sep 19, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Sep 19, 2018 | TE: | RLD: | No |
Complete Access Available with Subscription