Details for New Drug Application (NDA): 075356
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NDA 075356 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 075356
| Tradename: | PAROXETINE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | paroxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 075356
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 075356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075356 | ANDA | Major Pharmaceuticals | 0904-5676 | 0904-5676-61 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5676-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075356 | ANDA | Major Pharmaceuticals | 0904-5677 | 0904-5677-61 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5677-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 30, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 30, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jul 30, 2003 | TE: | AB | RLD: | No | ||||
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