Details for New Drug Application (NDA): 203854
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NDA 203854 describes PAROXETINE, which is a drug marketed by Prinston Inc, Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, Zydus Pharms Usa, and Actavis Labs Fl Inc, and is included in twenty-seven NDAs. It is available from six suppliers. Additional details are available on the PAROXETINE profile page.
The generic ingredient in PAROXETINE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
The generic ingredient in PAROXETINE is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
Summary for 203854
| Tradename: | PAROXETINE |
| Applicant: | Prinston Inc |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203854
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 203854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | paroxetine hydrochloride | TABLET;ORAL | 203854 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7985 | 0615-7985-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05) |
| PAROXETINE | paroxetine hydrochloride | TABLET;ORAL | 203854 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7985 | 0615-7985-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 31, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 31, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Oct 31, 2014 | TE: | AB | RLD: | No | ||||
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