Drug information for METADATE CD

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 10MG Prescription BX  METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC 21259
2010-10-20 Letter
2010-10-18 Label
2009-11-19 Medication Guide
2009-05-14 Letter
2009-04-23 Label
2008-08-29 Label
2008-08-28 Letter
2007-05-18 Other Important Information from FDA
2007-05-09 Letter
2007-05-07 Label
2006-08-14 Letter
2006-08-11 Label
2006-03-01 Letter
2004-06-09 Letter
2003-12-31 Review
2003-09-29 Letter
2003-06-22 Letter
2003-06-08 Letter
2002-04-09 Letter
2002-04-09 Label
2001-04-03 Label
CAPSULE, EXTENDED RELEASE; ORAL 20MG Prescription BX  METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC   "
CAPSULE, EXTENDED RELEASE; ORAL 30MG Prescription BX  METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC   "
CAPSULE, EXTENDED RELEASE; ORAL 40MG Prescription BX  METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC   "
CAPSULE, EXTENDED RELEASE; ORAL 50MG Prescription   METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC   "
CAPSULE, EXTENDED RELEASE; ORAL 60MG Prescription  (Reference Drug) METHYLPHENIDATE HYDROCHLORIDE Methylphenidate UCB INC   "

Drug Adverse Effects information for METADATE CD

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONTUSION 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER DELUSION 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER ENERGY INCREASED 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER EUPHORIC MOOD 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER HEAD INJURY 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER INSOMNIA 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER MANIA 3
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER OFF LABEL USE 1
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER OVERDOSE 2
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER SUICIDAL IDEATION 3
PS CATAPLEXY ALTERED STATE OF CONSCIOUSNESS 1
PS CATAPLEXY DYSPNOEA 1
PS CATAPLEXY FEELING ABNORMAL 1
PS CATAPLEXY MUSCLE SPASTICITY 1
PS CATAPLEXY MUSCLE TWITCHING 1
PS CATAPLEXY SOMNOLENCE 1
PS CATAPLEXY VOMITING 1
PS DEPRESSION ADRENOMEGALY 1
PS HYPERTENSION ALTERED STATE OF CONSCIOUSNESS 2
PS HYPERTENSION DYSPNOEA 2
PS HYPERTENSION FEELING ABNORMAL 2
PS HYPERTENSION MUSCLE SPASTICITY 2
PS HYPERTENSION MUSCLE TWITCHING 2
PS HYPERTENSION SOMNOLENCE 2
PS HYPERTENSION VOMITING 2
PS NARCOLEPSY ALTERED STATE OF CONSCIOUSNESS 4
PS NARCOLEPSY DYSPNOEA 4
PS NARCOLEPSY FEELING ABNORMAL 4
PS NARCOLEPSY MUSCLE SPASTICITY 4
PS NARCOLEPSY MUSCLE TWITCHING 4
PS NARCOLEPSY SOMNOLENCE 4
PS NARCOLEPSY VOMITING 4
C ASTROCYTOMA APHTHOUS STOMATITIS 1
C ASTROCYTOMA GINGIVAL ERYTHEMA 1
C ASTROCYTOMA ORAL PAIN 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER AFFECT LABILITY 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER MIGRAINE 1
C BIPOLAR DISORDER ASTEATOSIS 1
C BIPOLAR DISORDER ATRIAL FIBRILLATION 1
C BIPOLAR DISORDER CARDIAC ARREST 1
C BIPOLAR DISORDER CORNEAL SCAR 1
C BIPOLAR DISORDER DEPRESSION 1
C BIPOLAR DISORDER EYE EXCISION 1
C BIPOLAR DISORDER LUNG DISORDER 1
C BIPOLAR DISORDER MILIA 1
C BIPOLAR DISORDER PANIC ATTACK 1
C BIPOLAR DISORDER PERICARDIAL EFFUSION 1
C BIPOLAR DISORDER PIGMENTATION DISORDER 1
C BIPOLAR DISORDER PNEUMOTHORAX 1
C BIPOLAR DISORDER POST-TRAUMATIC STRESS DISORDER 1
C BIPOLAR DISORDER RESPIRATORY ARREST 1
C BIPOLAR DISORDER SCAR 1
C BIPOLAR DISORDER SHOCK HAEMORRHAGIC 1
C BIPOLAR DISORDER STEVENS-JOHNSON SYNDROME 1
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