DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090713
NDA 090713 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Sandoz Inc, Teva Pharms Usa, Exela Pharma Science, and Fresenius Kabi Usa, and is included in six NDAs. It is available from five suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.
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.
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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