Drug information for ELIGARD

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; SUBCUTANEOUS 7.5MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE luprolide acetate gel depot TOLMAR THERAP 21343
2011-12-20 Other Important Information from FDA
2011-04-11 Label
2011-04-11 Letter
2011-01-20 Letter
2011-01-20 Label
2010-10-13 Letter
2010-10-12 Label
2007-11-19 Letter
2007-11-13 Label
2004-01-14 Letter
2003-07-08 Letter
2002-04-01 Letter
2002-01-23 Letter
2002-01-23 Label
2002-01-23 Review
INJECTABLE; SUBCUTANEOUS 22.5MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE luprolide acetate gel depot TOLMAR THERAP 21379
2011-12-20 Other Important Information from FDA
2011-04-11 Label
2011-04-11 Letter
2011-01-20 Letter
2011-01-20 Label
2010-10-13 Letter
2010-10-12 Label
2008-07-31 Review
2007-11-19 Letter
2007-11-13 Label
2004-06-03 Letter
2002-07-24 Letter
2002-07-24 Label
2002-07-24 Review
INJECTABLE; SUBCUTANEOUS 30MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE luprolide acetate gel depot TOLMAR THERAP 21488
2011-12-20 Other Important Information from FDA
2011-04-11 Label
2011-04-11 Letter
2011-01-20 Letter
2011-01-20 Label
2010-10-13 Letter
2010-10-12 Label
2007-11-19 Letter
2007-11-13 Label
2004-06-03 Letter
2004-01-14 Letter
2003-05-08 Review
2003-02-13 Label
INJECTABLE; SUBCUTANEOUS 45MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE luprolide acetate gel depot TOLMAR THERAP 21731
2011-12-20 Other Important Information from FDA
2011-04-11 Label
2011-04-11 Letter
2011-01-20 Letter
2011-01-20 Label
2010-10-13 Letter
2010-10-12 Label
2007-11-19 Letter
2007-11-13 Label
2006-10-05 Letter
2006-09-27 Review

Drug Adverse Effects information for ELIGARD

Role code Indications Reaction # Reports
PS PROSTATE CANCER ABDOMINAL PAIN 1
PS PROSTATE CANCER CHEST PAIN 1
PS PROSTATE CANCER PULMONARY EMBOLISM 6
PS PROSTATIC SPECIFIC ANTIGEN INJECTION SITE NECROSIS 1
PS PROSTATIC SPECIFIC ANTIGEN INJECTION SITE ULCER 1
PS PROSTATIC SPECIFIC ANTIGEN SKIN NECROSIS 1
SS NAUSEA ANGINA PECTORIS 1
SS PAIN BRACHIAL PLEXOPATHY 2
SS PARKINSON'S DISEASE BRACHIAL PLEXOPATHY 6
SS PROPHYLAXIS ANGINA PECTORIS 2
SS PROSTATE CANCER ABDOMINAL PAIN LOWER 1
SS PROSTATE CANCER ANGINA PECTORIS 3
SS PROSTATE CANCER BRACHIAL PLEXOPATHY 2
SS PROSTATE CANCER PROSTATE CANCER 1
SS PROSTATE CANCER PULMONARY EMBOLISM 6
C ESSENTIAL HYPERTENSION ORTHOSTATIC HYPOTENSION 1
C HORMONE THERAPY CEREBROVASCULAR ACCIDENT 4
C HYPERTENSION ANAEMIA 1
C HYPERTENSION DRUG ADMINISTRATION ERROR 1
C HYPERTENSION ORAL CAVITY FISTULA 1
C HYPERTENSION OROANTRAL FISTULA 1
C HYPERTENSION OSTEONECROSIS OF JAW 1
C METASTASES TO BONE CARDIAC FAILURE CONGESTIVE 3
C METASTASES TO BONE DEATH 3
C METASTASES TO BONE DECUBITUS ULCER 3
C METASTASES TO BONE ORAL CAVITY FISTULA 1
C METASTASES TO BONE OROANTRAL FISTULA 1
C METASTASES TO BONE OSTEONECROSIS OF JAW 1
C METASTASES TO BONE POSTOPERATIVE WOUND COMPLICATION 3
C METASTASES TO BONE PULMONARY OEDEMA 3
C PROSTATE CANCER ANAEMIA 3
C PROSTATE CANCER DRUG ADMINISTRATION ERROR 3
C PROSTATE CANCER ORAL CAVITY FISTULA 1
C PROSTATE CANCER OROANTRAL FISTULA 1
C PROSTATE CANCER OSTEONECROSIS OF JAW 1
C PROSTATE CANCER SEPSIS 3
C PROSTATE CANCER METASTATIC ANAEMIA 1
C PROSTATE CANCER METASTATIC ANAPHYLACTIC REACTION 1
C PROSTATE CANCER METASTATIC ARRHYTHMIA 1
C PROSTATE CANCER METASTATIC ASTHENIA 2
C PROSTATE CANCER METASTATIC BLOOD PRESSURE INCREASED 2
C PROSTATE CANCER METASTATIC BODY TEMPERATURE INCREASED 1
C PROSTATE CANCER METASTATIC CARDIOTOXICITY 1
C PROSTATE CANCER METASTATIC CAROTID ARTERY STENOSIS 1
C PROSTATE CANCER METASTATIC CEREBROVASCULAR ACCIDENT 6
C PROSTATE CANCER METASTATIC CHILLS 1
C PROSTATE CANCER METASTATIC CONJUNCTIVITIS 1
C PROSTATE CANCER METASTATIC DIALYSIS 1
C PROSTATE CANCER METASTATIC FATIGUE 2
C PROSTATE CANCER METASTATIC HEART RATE INCREASED 1
C PROSTATE CANCER METASTATIC HYPERSENSITIVITY 1
C PROSTATE CANCER METASTATIC HYPOTENSION 1
C PROSTATE CANCER METASTATIC INFUSION RELATED REACTION 2
C PROSTATE CANCER METASTATIC LYMPHADENOPATHY 1
C PROSTATE CANCER METASTATIC MALAISE 1
C PROSTATE CANCER METASTATIC MASS 1
C PROSTATE CANCER METASTATIC MUCOSAL INFLAMMATION 1
C PROSTATE CANCER METASTATIC MULTI-ORGAN FAILURE 1
C PROSTATE CANCER METASTATIC NEOPLASM MALIGNANT 1
C PROSTATE CANCER METASTATIC NEOPLASM PROGRESSION 1
C PROSTATE CANCER METASTATIC OEDEMA PERIPHERAL 1
C PROSTATE CANCER METASTATIC PROSTATIC PAIN 1
C PROSTATE CANCER METASTATIC RENAL FAILURE 1
C PROSTATE CANCER METASTATIC RENAL FAILURE ACUTE 1
C PROSTATE CANCER METASTATIC SINUS CONGESTION 2
C PROSTATE CANCER METASTATIC SKIN TOXICITY 1
C PROSTATE CANCER METASTATIC SOMNOLENCE 2
C PROSTATE CANCER METASTATIC THROMBOCYTOPENIA 1
C PROSTATE CANCER STAGE IV ACUTE HEPATIC FAILURE 2
C PROSTATE CANCER STAGE IV TRANSAMINASES INCREASED 2
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