Details for New Drug Application (NDA): 202951
NDA 202951 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from thirteen suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.
The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 202951
| Tradename: | PALONOSETRON HYDROCHLORIDE |
| Applicant: | Avet Lifesciences |
| Ingredient: | palonosetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Jun 29, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Jun 29, 2021 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
