Details for New Drug Application (NDA): 077584
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The generic ingredient in PAROXETINE HYDROCHLORIDE 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 077584
Tradename: | PAROXETINE HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077584
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 077584
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 077584 | ANDA | A-S Medication Solutions | 50090-0850 | 50090-0850-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0850-0) |
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 077584 | ANDA | A-S Medication Solutions | 50090-0850 | 50090-0850-1 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-0850-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 7, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 7, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Mar 7, 2007 | TE: | AB | RLD: | No |
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