Details for New Drug Application (NDA): 078902
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NDA 078902 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-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 078902
| Tradename: | PAROXETINE HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078902
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 078902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078902 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7001 | 0378-7001-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-10) |
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078902 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7001 | 0378-7001-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7001-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Mar 13, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Mar 13, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Mar 13, 2008 | TE: | AB | RLD: | No | ||||
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