Details for New Drug Application (NDA): 215003
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NDA 215003 describes PAROXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Novitium Pharma, 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, Norvium Bioscience, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-four NDAs. It is available from forty 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-three 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-three suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 215003
| Tradename: | PAROXETINE HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215003
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 215003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | SUSPENSION;ORAL | 215003 | ANDA | ANI Pharmaceuticals, Inc. | 70954-319 | 70954-319-10 | 250 mL in 1 BOTTLE (70954-319-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
| Approval Date: | Sep 3, 2021 | TE: | AB | RLD: | No | ||||
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