Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020885

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PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020885
Product Number: 001
Approval Date: Oct 9, 1998
Applicant Holder Full Name: APOTEX TECHNOLOGIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020885
Product Number: 002
Approval Date: Oct 9, 1998
Applicant Holder Full Name: APOTEX TECHNOLOGIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020885
Product Number: 003
Approval Date: Oct 9, 1998
Applicant Holder Full Name: APOTEX TECHNOLOGIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PAXIL (PAROXETINE HYDROCHLORIDE)
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: PAROXETINE HYDROCHLORIDE
Proprietary Name: PAXIL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020885
Product Number: 004
Approval Date: Oct 9, 1998
Applicant Holder Full Name: APOTEX TECHNOLOGIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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