Details for New Drug Application (NDA): 020710
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The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 020710
Tradename: | PAXIL |
Applicant: | Apotex |
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) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
Approval Date: | Jun 25, 1997 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020710
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