Drug information for BROVANA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION; INHALATION EQ 0.015MG BASE/2ML Prescription  (Reference Drug) ARFORMOTEROL TARTRATE formoterol SUNOVION 21912
2011-09-07 Letter

2011-07-18 Letter

2011-07-18 Label

2011-03-01 Other

2011-02-24 Label

2011-02-24 Medication Guide

2011-02-18 Letter

2011-02-07 Letter

2011-02-04 Medication Guide

2010-06-03 Letter

2010-06-02 Label

2009-11-16 Medication Guide

2009-04-14 Summary Review

2009-04-14 Review

2008-01-09 Letter

2008-01-08 Label

2007-02-20 Other Important Information from FDA

2006-10-13 Letter

2006-10-11 Label

Drug Adverse Effects information for BROVANA

Role code Indications Reaction # Reports
PS CHRONIC OBSTRUCTIVE PULMONARY DISEASE PNEUMONIA 1
PS CHRONIC OBSTRUCTIVE PULMONARY DISEASE STOMATITIS 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE COUGH 1
SS DYSPNOEA BLOOD PRESSURE INCREASED 2
SS DYSPNOEA CHEST PAIN 2
SS DYSPNOEA DYSPEPSIA 2
SS DYSPNOEA HEART RATE INCREASED 2
SS DYSPNOEA MALAISE 2
SS MULTIPLE ALLERGIES BLOOD PRESSURE INCREASED 1
SS MULTIPLE ALLERGIES CHEST PAIN 1
SS MULTIPLE ALLERGIES DYSPEPSIA 1
SS MULTIPLE ALLERGIES HEART RATE INCREASED 1
SS MULTIPLE ALLERGIES MALAISE 1
SS PRODUCT USED FOR UNKNOWN INDICATION BLOOD PRESSURE INCREASED 2
SS PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 2
SS PRODUCT USED FOR UNKNOWN INDICATION COUGH 1
SS PRODUCT USED FOR UNKNOWN INDICATION DYSPEPSIA 2
SS PRODUCT USED FOR UNKNOWN INDICATION HEART RATE INCREASED 2
SS PRODUCT USED FOR UNKNOWN INDICATION MALAISE 2
C ANKYLOSING SPONDYLITIS ARTHRALGIA 1
C ANKYLOSING SPONDYLITIS BLISTER 1
C ANKYLOSING SPONDYLITIS DIVERTICULUM 1
C ANKYLOSING SPONDYLITIS DUODENITIS 1
C ANKYLOSING SPONDYLITIS DYSPNOEA 1
C ANKYLOSING SPONDYLITIS HEPATIC ENZYME INCREASED 1
C ANKYLOSING SPONDYLITIS HERPES ZOSTER 1
C ANKYLOSING SPONDYLITIS HIATUS HERNIA 1
C ANKYLOSING SPONDYLITIS PLATELET COUNT DECREASED 1
C ANKYLOSING SPONDYLITIS POST PROCEDURAL INFECTION 1
C ANKYLOSING SPONDYLITIS RASH 1
C BRONCHIECTASIS BRONCHOSPASM 1
C BRONCHIECTASIS CANDIDIASIS 1
C BRONCHIECTASIS CHEST DISCOMFORT 1
C BRONCHIECTASIS DEVICE MALFUNCTION 1
C BRONCHIECTASIS EMPHYSEMA 1
C BRONCHIECTASIS OXYGEN SATURATION DECREASED 1
C BRONCHIECTASIS PULMONARY CONGESTION 1
C BRONCHIECTASIS TOOTH DISORDER 1
C CHRONIC MYELOID LEUKAEMIA ATRIAL FIBRILLATION 1
C CHRONIC MYELOID LEUKAEMIA CEREBROVASCULAR ACCIDENT 1
C CHRONIC MYELOID LEUKAEMIA CHEST PAIN 1
C CHRONIC MYELOID LEUKAEMIA COMPRESSION FRACTURE 1
C CHRONIC MYELOID LEUKAEMIA COUGH 1
C CHRONIC MYELOID LEUKAEMIA FATIGUE 1
C CHRONIC MYELOID LEUKAEMIA HERPES ZOSTER 1
C CHRONIC MYELOID LEUKAEMIA LYMPHADENOPATHY MEDIASTINAL 1
C CHRONIC MYELOID LEUKAEMIA OEDEMA PERIPHERAL 1
C CHRONIC MYELOID LEUKAEMIA PAIN 1
C CHRONIC MYELOID LEUKAEMIA PRURITUS 1
C CHRONIC MYELOID LEUKAEMIA PULMONARY FIBROSIS 1
C CHRONIC MYELOID LEUKAEMIA RASH 1
C CHRONIC MYELOID LEUKAEMIA RASH PRURITIC 1
C CHRONIC MYELOID LEUKAEMIA RIB FRACTURE 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE JOINT SWELLING 2
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE MUSCLE SPASMS 1
C CHRONIC OBSTRUCTIVE PULMONARY DISEASE OEDEMA PERIPHERAL 2
C MYELODYSPLASTIC SYNDROME COLITIS ULCERATIVE 2
C PRODUCT USED FOR UNKNOWN INDICATION CHILLS 2
C PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 4
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 4
C PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA 2
C PRODUCT USED FOR UNKNOWN INDICATION ESCHERICHIA URINARY TRACT INFECTION 4
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 4
C PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 4
C PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 2
C PRODUCT USED FOR UNKNOWN INDICATION RASH 4
C PRODUCT USED FOR UNKNOWN INDICATION SKIN BURNING SENSATION 4
C PRODUCT USED FOR UNKNOWN INDICATION SWELLING FACE 4
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