Details for New Drug Application (NDA): 021372
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NDA 021372 describes ALOXI, which is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ALOXI profile page.
The generic ingredient in ALOXI 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.
The generic ingredient in ALOXI 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 021372
| Tradename: | ALOXI |
| Applicant: | Helsinn Hlthcare |
| Ingredient: | palonosetron hydrochloride |
| Patents: | 13 |
Suppliers and Packaging for NDA: 021372
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372 | NDA AUTHORIZED GENERIC | Cipla USA Inc. | 69097-927 | 69097-927-35 | 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 25, 2003 | TE: | RLD: | Yes | |||||
| Patent: | 7,947,724*PED | Patent Expiration: | Jul 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,947,725*PED | Patent Expiration: | Jul 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,960,424*PED | Patent Expiration: | Jul 30, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021372
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | 9,173,942*PED | ⤷ Subscribe |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | 8,518,981*PED | ⤷ Subscribe |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | 9,439,854*PED | ⤷ Subscribe |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | 8,598,218*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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