Details for New Drug Application (NDA): 078406
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NDA 078406 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 078406
| Tradename: | PAROXETINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078406
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 078406
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078406 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8359 | 0615-8359-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8359-39) |
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078406 | ANDA | Aurolife Pharma LLC | 13107-154 | 13107-154-01 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-154-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 25, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 25, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jul 25, 2007 | TE: | AB | RLD: | No | ||||
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