Details for New Drug Application (NDA): 020031
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The generic ingredient in PAXIL 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 020031
Tradename: | PAXIL |
Applicant: | Apotex |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 020031
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 020031
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031 | NDA | Apotex Corp | 60505-4517 | 60505-4517-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4517-3) |
PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031 | NDA | Apotex Corp | 60505-4518 | 60505-4518-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4518-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Dec 29, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Dec 29, 1992 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Dec 29, 1992 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020031
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-002 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-002 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-004 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-005 | Dec 29, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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