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Details for New Drug Application (NDA): 020710
NDA 020710 describes PAXIL, which is a drug marketed by Apotex Technologies and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the PAXIL profile page.
The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020710
| Tradename: | PAXIL |
| Applicant: | Apotex Technologies |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020710
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 020710
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710 | NDA | Apotex Corp | 60505-0402 | 60505-0402-5 | 250 mL in 1 BOTTLE (60505-0402-5) |
Paragraph IV (Patent) Challenges for 020710
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PAXIL | SUSPENSION;ORAL | paroxetine hydrochloride | 020710 | 2005-02-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
| Approval Date: | Jun 25, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020710
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex Technologies | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | Start Trial | Start Trial |
| Apotex Technologies | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | Start Trial | Start Trial |
| Apotex Technologies | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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