Details for New Drug Application (NDA): 075716
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The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 075716
Tradename: | PAROXETINE HYDROCHLORIDE |
Applicant: | Mylan Pharms Inc |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 8, 2004 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 8, 2004 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Mar 8, 2004 | TE: | RLD: | No |
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