Details for New Drug Application (NDA): 201533
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NDA 201533 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 201533
| Tradename: | PALONOSETRON HYDROCHLORIDE |
| Applicant: | Dr Reddys |
| Ingredient: | palonosetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 201533
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 201533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533 | ANDA | NorthStar Rx LLC | 16714-834 | 16714-834-01 | 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE |
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533 | ANDA | Dr.Reddy's Laboratories Limited | 55111-694 | 55111-694-07 | 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Apr 21, 2016 | 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: | Apr 21, 2016 | TE: | AP | RLD: | No | ||||
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