Drug information for PEXEVA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
EQ 10MG BASE
Prescription
PAROXETINE MESYLATE
Paroxetine
NOVEN THERAP
21299
2011-04-29 Label
2011-04-29 Letter
2011-04-29 Medication Guide
2010-02-05 Letter
2010-02-04 Label
2010-02-04 Medication Guide
2009-11-20 Medication Guide
2009-02-04 Label
2009-02-03 Letter
2008-03-07 Label
2008-03-07 Letter
2007-10-10 Label
2007-10-10 Letter
2007-09-26 Review
2007-08-07 Letter
2007-08-06 Label
2007-05-09 Other Important Information from FDA
2006-12-28 Letter
2006-12-28 Letter
2006-12-28 Letter
2006-12-14 Label
2006-12-14 Label
2006-12-14 Label
2005-01-13 Label
2005-01-13 Letter
2004-08-31 Letter
2004-06-18 Review
2004-06-18 Letter
2004-06-18 Label
2004-06-18 Letter
2004-06-18 Label
2003-08-28 Letter
TABLET; ORAL
EQ 20MG BASE
Prescription
PAROXETINE MESYLATE
Paroxetine
NOVEN THERAP
"
TABLET; ORAL
EQ 30MG BASE
Prescription
PAROXETINE MESYLATE
Paroxetine
NOVEN THERAP
"
TABLET; ORAL
EQ 40MG BASE
Prescription
(Reference Drug)
PAROXETINE MESYLATE
Paroxetine
NOVEN THERAP
"
Drug Adverse Effects information for PEXEVA
Role code
Indications
Reaction
# Reports
C
BIPOLAR II DISORDER
ELECTROCARDIOGRAM QT PROLONGED
1
C
BIPOLAR II DISORDER
VENTRICULAR EXTRASYSTOLES
1
C
MIGRAINE
DRUG INEFFECTIVE
1
C
MIGRAINE
DYSPNOEA
1
C
NECK PAIN
DRUG INEFFECTIVE
1
C
NECK PAIN
DYSPNOEA
1
C
TESTICULAR PAIN
DRUG INEFFECTIVE
1
C
TESTICULAR PAIN
DYSPNOEA
1
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