Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021299

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PEXEVA (PAROXETINE MESYLATE)
EQ 10MG BASE
Marketing Status: Discontinued

Active Ingredient: PAROXETINE MESYLATE
Proprietary Name: PEXEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021299
Product Number: 001
Approval Date: Jul 3, 2003
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

PEXEVA (PAROXETINE MESYLATE)
EQ 20MG BASE
Marketing Status: Discontinued

Active Ingredient: PAROXETINE MESYLATE
Proprietary Name: PEXEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021299
Product Number: 002
Approval Date: Jul 3, 2003
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

PEXEVA (PAROXETINE MESYLATE)
EQ 30MG BASE
Marketing Status: Discontinued

Active Ingredient: PAROXETINE MESYLATE
Proprietary Name: PEXEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021299
Product Number: 003
Approval Date: Jul 3, 2003
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

PEXEVA (PAROXETINE MESYLATE)
EQ 40MG BASE
Marketing Status: Discontinued

Active Ingredient: PAROXETINE MESYLATE
Proprietary Name: PEXEVA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021299
Product Number: 004
Approval Date: Jul 3, 2003
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information