Details for New Drug Application (NDA): 217280
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NDA 217280 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Novitium Pharma, Alembic, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Oxford Pharms, Pharmobedient, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-five NDAs. It is available from forty-one suppliers. Additional details are available on the PAROXETINE HYDROCHLORIDE profile page.
The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 217280
| Tradename: | PAROXETINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 217280
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 217280
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217280 | ANDA | Alembic Pharmaceuticals Limited | 46708-767 | 46708-767-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30) |
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 217280 | ANDA | Alembic Pharmaceuticals Limited | 46708-767 | 46708-767-91 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Sep 24, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
| Approval Date: | Sep 24, 2025 | TE: | AB | RLD: | No | ||||
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