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Details for New Drug Application (NDA): 090713
The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 090713
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Teva Pharms Usa |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Therapeutic Class: | Antiemetics |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090713
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 090713
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 090713 | ANDA | Teva Parenteral Medicines, Inc. | 0703-4094 | N | 0703-4094-01 |
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: | Mar 23, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Mar 23, 2018 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Sep 19, 2018 | ||||||||
Regulatory Exclusivity Use: | PATENT CHALLENGE |
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