Details for New Drug Application (NDA): 209748
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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 209748
Tradename: | PAROXETINE HYDROCHLORIDE |
Applicant: | Prinston Inc |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 12.5MG BASE | ||||
Approval Date: | Jan 4, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jan 4, 2024 | TE: | AB | RLD: | No |
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