Details for New Drug Application (NDA): 020936
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The generic ingredient in PAXIL CR 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 020936
Tradename: | PAXIL CR |
Applicant: | Apotex |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 020936
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 020936
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936 | NDA AUTHORIZED GENERIC | Apotex Corp | 60505-1316 | 60505-1316-3 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1316-3) |
PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936 | NDA AUTHORIZED GENERIC | Apotex Corp | 60505-1317 | 60505-1317-3 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 12.5MG BASE | ||||
Approval Date: | Feb 16, 1999 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Feb 16, 1999 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
Approval Date: | Dec 6, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020936
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-001 | Feb 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL CR | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936-003 | Dec 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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