Details for New Drug Application (NDA): 020885
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The generic ingredient in PAXIL 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 020885
Tradename: | PAXIL |
Applicant: | Apotex |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 9, 1998 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 9, 1998 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 9, 1998 | TE: | RLD: | Yes |
Expired US Patents for NDA 020885
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-001 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-002 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Apotex | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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