Drug information for ZIAGEN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION; ORAL EQ 20MG BASE/ML Prescription  (Reference Drug) ABACAVIR SULFATE abacavir VIIV HLTHCARE 20978
2012-03-19 Letter

2012-03-16 Label

2011-11-22 Label

2011-11-22 Letter

2011-05-17 Letter

2010-09-01 Other

2010-08-10 Letter

2010-08-10 Medication Guide

2009-12-18 Other

2009-08-25 Letter

2009-08-25 Letter

2009-01-02 Label

2008-12-29 Letter

2008-07-23 Letter

2008-07-22 Label

2007-09-26 Review

2007-09-26 Review

2007-09-26 Review

2007-05-09 Label

2007-05-09 Letter

2007-02-28 Medication Guide

2006-08-21 Letter

2006-08-14 Label

2004-08-05 Label

2004-08-05 Letter

2004-07-28 Letter

2004-07-28 Label

2004-05-03 Label

2004-04-20 Letter

2004-04-14 Review

2003-12-17 Medication Guide

2003-12-12 Other Important Information from FDA

2003-09-25 Label

2003-07-28 Letter

2002-10-02 Label

2002-10-02 Letter

2002-08-14 Label

2002-08-14 Letter

2002-01-28 Letter

1998-12-17 Review

1998-12-17 Letter

1998-12-17 Label
TABLET; ORAL EQ 300MG BASE Prescription  (Reference Drug) ABACAVIR SULFATE abacavir VIIV HLTHCARE 20977
2012-03-19 Letter

2012-03-16 Label

2011-11-22 Label

2011-11-22 Letter

2011-05-17 Letter

2010-09-01 Other

2010-08-10 Letter

2010-08-10 Medication Guide

2009-12-18 Other

2009-08-25 Letter

2009-08-25 Letter

2009-01-02 Label

2008-12-29 Letter

2008-07-23 Letter

2008-07-22 Label

2007-09-26 Review

2007-09-26 Review

2007-05-09 Label

2007-05-09 Letter

2007-02-28 Medication Guide

2006-08-21 Letter

2006-08-14 Label

2004-08-05 Label

2004-08-05 Letter

2004-07-28 Label

2004-07-28 Letter

2004-05-03 Label

2004-04-20 Letter

2004-04-14 Review

2003-12-12 Other Important Information from FDA

2003-09-25 Label

2003-07-28 Letter

2002-10-02 Label

2002-10-02 Letter

2002-08-14 Label

2002-08-14 Letter

2002-01-28 Letter

1998-12-17 Letter

1998-12-17 Review

1998-12-17 Label

Drug Adverse Effects information for ZIAGEN

Role code Indications Reaction # Reports
PS ANTIRETROVIRAL THERAPY ABORTION SPONTANEOUS 6
PS ANTIRETROVIRAL THERAPY CERVIX OPERATION 6
PS ANTIRETROVIRAL THERAPY MATERNAL EXPOSURE DURING PREGNANCY 6
PS ANTIRETROVIRAL THERAPY NORMAL LABOUR 6
PS ANTIRETROVIRAL THERAPY PYREXIA 6
PS ANTIRETROVIRAL THERAPY RASH 6
PS ANTIRETROVIRAL THERAPY VAGINAL HAEMORRHAGE 6
PS ANTIVIRAL TREATMENT ABORTION SPONTANEOUS 3
PS ANTIVIRAL TREATMENT MATERNAL EXPOSURE DURING PREGNANCY 3
PS HIV INFECTION CARDIAC FAILURE 3
SS ANTIRETROVIRAL THERAPY ABORTION SPONTANEOUS 6
SS ANTIRETROVIRAL THERAPY MATERNAL EXPOSURE DURING PREGNANCY 6
SS ANTIRETROVIRAL THERAPY PREGNANCY 6
SS DEPRESSION GOUT 1
SS DIARRHOEA GOUT 3
SS DRUG ABUSE ABORTION SPONTANEOUS 1
SS DRUG ABUSE MATERNAL EXPOSURE DURING PREGNANCY 1
SS DRUG ABUSE PYREXIA 1
SS DRUG ABUSE RASH 1
SS FOETAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS 8
SS FOETAL EXPOSURE DURING PREGNANCY CELL DEATH 8
SS FOETAL EXPOSURE DURING PREGNANCY EXOMPHALOS 8
SS FOETAL EXPOSURE DURING PREGNANCY MATERNAL DRUGS AFFECTING FOETUS 8
SS FOETAL EXPOSURE DURING PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY 8
SS HAEMARTHROSIS ALANINE AMINOTRANSFERASE INCREASED 1
SS HAEMARTHROSIS ASPARTATE AMINOTRANSFERASE INCREASED 1
SS HAEMARTHROSIS DIZZINESS 1
SS HAEMARTHROSIS PALPITATIONS 1
SS HAEMARTHROSIS PULMONARY HYPERTENSION 1
SS HIV INFECTION ABORTION SPONTANEOUS 6
SS HIV INFECTION ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 3
SS HIV INFECTION ALANINE AMINOTRANSFERASE INCREASED 8
SS HIV INFECTION ANAL FISTULA 10
SS HIV INFECTION APHASIA 3
SS HIV INFECTION APPARENT LIFE THREATENING EVENT 10
SS HIV INFECTION ASPARTATE AMINOTRANSFERASE INCREASED 8
SS HIV INFECTION ASTHENIA 3
SS HIV INFECTION BODY TEMPERATURE INCREASED 12
SS HIV INFECTION CALCULUS URINARY 10
SS HIV INFECTION CYTOLYTIC HEPATITIS 3
SS HIV INFECTION DIZZINESS 18
SS HIV INFECTION ENDOLYMPHATIC HYDROPS 10
SS HIV INFECTION EOSINOPHILIA 3
SS HIV INFECTION GOUT 3
SS HIV INFECTION GYNAECOMASTIA 10
SS HIV INFECTION HYPERAEMIA 12
SS HIV INFECTION HYPERSENSITIVITY 12
SS HIV INFECTION INFLAMMATION 3
SS HIV INFECTION LEUKOCYTOSIS 3
SS HIV INFECTION LYMPHADENOPATHY 3
SS HIV INFECTION MATERNAL EXPOSURE DURING PREGNANCY 18
SS HIV INFECTION MENIERE'S DISEASE 10
SS HIV INFECTION NEUTROPENIA 2
SS HIV INFECTION ODYNOPHAGIA 3
SS HIV INFECTION ORAL MUCOSA EROSION 3
SS HIV INFECTION PALPITATIONS 18
SS HIV INFECTION PANCREATITIS 10
SS HIV INFECTION PERICARDITIS 3
SS HIV INFECTION PULMONARY HYPERTENSION 18
SS HIV INFECTION PYREXIA 9
SS HIV INFECTION RASH 9
SS HIV INFECTION RASH GENERALISED 15
SS HIV INFECTION RASH MACULAR 3
SS HIV INFECTION RASH MORBILLIFORM 3
SS HIV INFECTION RASH PRURITIC 3
SS HIV INFECTION RASH PUSTULAR 3
SS HIV INFECTION RENAL FAILURE ACUTE 13
SS HIV INFECTION SEBORRHOEIC DERMATITIS 3
SS HIV INFECTION STOMATITIS 3
SS HIV INFECTION THROMBOCYTOPENIA 3
SS HYPERLIPIDAEMIA GOUT 2
SS INSOMNIA GOUT 3
SS MATERNAL EXPOSURE TIMING UNSPECIFIED ABORTION SPONTANEOUS 6
SS MATERNAL EXPOSURE TIMING UNSPECIFIED DEATH 6
SS MATERNAL EXPOSURE TIMING UNSPECIFIED EXOMPHALOS 6
SS MATERNAL EXPOSURE TIMING UNSPECIFIED FOETAL EXPOSURE DURING PREGNANCY 6
SS MATERNAL EXPOSURE TIMING UNSPECIFIED PREMATURE RUPTURE OF MEMBRANES 6
SS MYCOBACTERIUM TEST GOUT 1
SS POSTOPERATIVE CARE ANAL FISTULA 2
SS POSTOPERATIVE CARE CALCULUS URINARY 2
SS POSTOPERATIVE CARE RENAL FAILURE ACUTE 2
SS PROCEDURAL PAIN ANAL FISTULA 2
SS PROCEDURAL PAIN CALCULUS URINARY 2
SS PROCEDURAL PAIN RENAL FAILURE ACUTE 2
SS PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 3
SS PRODUCT USED FOR UNKNOWN INDICATION ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION APHASIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION CYTOLYTIC HEPATITIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION EOSINOPHILIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION INFLAMMATION 4
SS PRODUCT USED FOR UNKNOWN INDICATION LEUKOCYTOSIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION LYMPHADENOPATHY 4
SS PRODUCT USED FOR UNKNOWN INDICATION MATERNAL EXPOSURE DURING PREGNANCY 3
SS PRODUCT USED FOR UNKNOWN INDICATION NEUTROPENIA 3
SS PRODUCT USED FOR UNKNOWN INDICATION ODYNOPHAGIA 4
SS PRODUCT USED FOR UNKNOWN INDICATION ORAL MUCOSA EROSION 4
SS PRODUCT USED FOR UNKNOWN INDICATION PERICARDITIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION PREGNANCY 2
SS PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 5
SS PRODUCT USED FOR UNKNOWN INDICATION RASH 5
SS PRODUCT USED FOR UNKNOWN INDICATION RASH GENERALISED 4
SS PRODUCT USED FOR UNKNOWN INDICATION RASH MACULAR 4
SS PRODUCT USED FOR UNKNOWN INDICATION RASH MORBILLIFORM 4
SS PRODUCT USED FOR UNKNOWN INDICATION RASH PRURITIC 4
SS PRODUCT USED FOR UNKNOWN INDICATION RASH PUSTULAR 4
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 4
SS PRODUCT USED FOR UNKNOWN INDICATION SEBORRHOEIC DERMATITIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION STOMATITIS 4
SS PRODUCT USED FOR UNKNOWN INDICATION THROMBOCYTOPENIA 4
SS SCHIZOPHRENIA ANAL FISTULA 2
SS SCHIZOPHRENIA CALCULUS URINARY 2
SS SCHIZOPHRENIA RENAL FAILURE ACUTE 2
C ANTIBIOTIC PROPHYLAXIS CONVULSION 1
C ANTIVIRAL TREATMENT ABORTION SPONTANEOUS 3
C CORONARY ARTERY BYPASS ANHEDONIA 2
C CORONARY ARTERY BYPASS ANXIETY 2
C CORONARY ARTERY BYPASS CARDIAC DISORDER 2
C CORONARY ARTERY BYPASS CEREBROVASCULAR ACCIDENT 2
C CORONARY ARTERY BYPASS DEATH 2
C CORONARY ARTERY BYPASS DEPRESSION 2
C CORONARY ARTERY BYPASS FEAR 2
C CORONARY ARTERY BYPASS INJURY 2
C CORONARY ARTERY BYPASS ORGAN FAILURE 2
C CORONARY ARTERY BYPASS PAIN 2
C CORONARY ARTERY BYPASS RENAL FAILURE 2
C CORONARY ARTERY BYPASS RENAL IMPAIRMENT 2
C CORONARY ARTERY BYPASS RENAL INJURY 2
C CORONARY ARTERY BYPASS UNEVALUABLE EVENT 2
C CYTOMEGALOVIRUS CHORIORETINITIS BLOOD ALKALINE PHOSPHATASE INCREASED 2
C CYTOMEGALOVIRUS CHORIORETINITIS BRONCHOPULMONARY ASPERGILLOSIS 2
C CYTOMEGALOVIRUS CHORIORETINITIS CYTOMEGALOVIRUS CHORIORETINITIS 2
C CYTOMEGALOVIRUS CHORIORETINITIS GAMMA-GLUTAMYLTRANSFERASE INCREASED 2
C CYTOMEGALOVIRUS CHORIORETINITIS LYMPHOMA 2
C CYTOMEGALOVIRUS CHORIORETINITIS PLATELET COUNT DECREASED 2
C EPILEPSY CONVULSION 1
C HIV INFECTION ABORTION INDUCED 5
C HIV INFECTION ABORTION SPONTANEOUS 6
C HIV INFECTION BLOOD ALKALINE PHOSPHATASE INCREASED 12
C HIV INFECTION BRONCHOPULMONARY ASPERGILLOSIS 12
C HIV INFECTION CONVULSION 3
C HIV INFECTION CYTOMEGALOVIRUS CHORIORETINITIS 12
C HIV INFECTION DEPRESSION 2
C HIV INFECTION ECZEMA 2
C HIV INFECTION FANCONI SYNDROME 5
C HIV INFECTION GAMMA-GLUTAMYLTRANSFERASE INCREASED 12
C HIV INFECTION GENERAL PHYSICAL HEALTH DETERIORATION 5
C HIV INFECTION HIDRADENITIS 1
C HIV INFECTION LIPODYSTROPHY ACQUIRED 2
C HIV INFECTION LIPOHYPERTROPHY 2
C HIV INFECTION LYMPHOMA 12
C HIV INFECTION PHARYNGOTONSILLITIS 2
C HIV INFECTION PLATELET COUNT DECREASED 12
C HIV INFECTION RASH 5
C HIV INFECTION RENAL FAILURE ACUTE 5
C HIV INFECTION RENAL TUBULAR DISORDER 5
C HIV INFECTION SINUSITIS 2
C HIV INFECTION SQUAMOUS CELL CARCINOMA 4
C HIV INFECTION SUICIDE ATTEMPT 2
C MITRAL VALVE REPAIR ANHEDONIA 1
C MITRAL VALVE REPAIR ANXIETY 1
C MITRAL VALVE REPAIR CARDIAC DISORDER 1
C MITRAL VALVE REPAIR CEREBROVASCULAR ACCIDENT 1
C MITRAL VALVE REPAIR DEATH 1
C MITRAL VALVE REPAIR DEPRESSION 1
C MITRAL VALVE REPAIR FEAR 1
C MITRAL VALVE REPAIR INJURY 1
C MITRAL VALVE REPAIR ORGAN FAILURE 1
C MITRAL VALVE REPAIR PAIN 1
C MITRAL VALVE REPAIR RENAL FAILURE 1
C MITRAL VALVE REPAIR RENAL IMPAIRMENT 1
C MITRAL VALVE REPAIR RENAL INJURY 1
C MITRAL VALVE REPAIR UNEVALUABLE EVENT 1
C NEUROPATHY PERIPHERAL CONVULSION 1
C OPPORTUNISTIC INFECTION PROPHYLAXIS BLOOD ALKALINE PHOSPHATASE INCREASED 2
C OPPORTUNISTIC INFECTION PROPHYLAXIS BRONCHOPULMONARY ASPERGILLOSIS 2
C OPPORTUNISTIC INFECTION PROPHYLAXIS CYTOMEGALOVIRUS CHORIORETINITIS 2
C OPPORTUNISTIC INFECTION PROPHYLAXIS GAMMA-GLUTAMYLTRANSFERASE INCREASED 2
C OPPORTUNISTIC INFECTION PROPHYLAXIS LYMPHOMA 2
C OPPORTUNISTIC INFECTION PROPHYLAXIS PLATELET COUNT DECREASED 2
C PRODUCT USED FOR UNKNOWN INDICATION ABORTION INDUCED 1
C PRODUCT USED FOR UNKNOWN INDICATION ABORTION SPONTANEOUS 1
C PRODUCT USED FOR UNKNOWN INDICATION FANCONI SYNDROME 3
C PRODUCT USED FOR UNKNOWN INDICATION GENERAL PHYSICAL HEALTH DETERIORATION 3
C PRODUCT USED FOR UNKNOWN INDICATION RASH 1
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE ACUTE 3
C PRODUCT USED FOR UNKNOWN INDICATION RENAL TUBULAR DISORDER 3
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