Details for New Drug Application (NDA): 213612
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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 213612
Tradename: | PAROXETINE HYDROCHLORIDE |
Applicant: | Epic Pharma Llc |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213612
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 213612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213612 | ANDA | Sinotherapeutics Inc. | 69986-011 | 69986-011-01 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69986-011-01) |
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213612 | ANDA | Sinotherapeutics Inc. | 69986-011 | 69986-011-18 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (69986-011-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 12.5MG BASE | ||||
Approval Date: | Aug 11, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Aug 11, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
Approval Date: | May 26, 2022 | TE: | RLD: | No |
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