Drug information for LUPRON DEPOT-PED

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 11.25MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE 20263
2011-12-20 Other Important Information from FDA

2011-10-12 Letter

2011-10-12 Label

2011-08-17 Letter

2011-08-15 Label

2010-09-02 Letter

2010-08-30 Label

2009-06-30 Letter

2009-06-29 Label

2008-08-05 Letter

2007-07-09 Review

2007-07-09 Review

2007-07-09 Review

2007-07-09 Review

2006-02-22 Letter

2006-02-22 Label

2005-11-18 Letter

2005-11-17 Label

2004-04-05 Label

2004-03-10 Letter

2003-12-24 Letter

2003-10-31 Letter

2002-09-24 Letter
INJECTABLE; INJECTION 11.25MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "
INJECTABLE; INJECTION 15MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "
INJECTABLE; INJECTION 3.75MG/VIAL,7.5MG/VIAL Discontinued   LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "
INJECTABLE; INJECTION 30MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "
INJECTABLE; INJECTION 7.5MG/VIAL Prescription  (Reference Drug) LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "
INJECTABLE; INJECTION 7.5MG/VIAL,7.5MG/VIAL Discontinued   LEUPROLIDE ACETATE Leuprolide ABBOTT ENDOCRINE   "

Drug Adverse Effects information for LUPRON DEPOT-PED

Role code Indications Reaction # Reports
PS CONVULSION DIARRHOEA 2
PS CONVULSION PYREXIA 2
PS CONVULSION URINARY TRACT INFECTION 2
PS CONVULSION VIRAL INFECTION 2
PS CONVULSION VOMITING 2
PS HYPERTONIA DIARRHOEA 1
PS HYPERTONIA PYREXIA 1
PS HYPERTONIA URINARY TRACT INFECTION 1
PS HYPERTONIA VIRAL INFECTION 1
PS HYPERTONIA VOMITING 1
PS MUSCLE DISORDER DIARRHOEA 1
PS MUSCLE DISORDER PYREXIA 1
PS MUSCLE DISORDER URINARY TRACT INFECTION 1
PS MUSCLE DISORDER VIRAL INFECTION 1
PS MUSCLE DISORDER VOMITING 1
PS PRECOCIOUS PUBERTY DIARRHOEA 1
PS PRECOCIOUS PUBERTY INJECTION SITE ABSCESS STERILE 1
PS PRECOCIOUS PUBERTY INJECTION SITE INFECTION 1
PS PRECOCIOUS PUBERTY INJECTION SITE PAIN 1
PS PRECOCIOUS PUBERTY INJECTION SITE SWELLING 1
PS PRECOCIOUS PUBERTY PAIN 1
PS PRECOCIOUS PUBERTY PURULENT DISCHARGE 1
PS PRECOCIOUS PUBERTY PYREXIA 1
PS PRECOCIOUS PUBERTY URINARY TRACT INFECTION 1
PS PRECOCIOUS PUBERTY VIRAL INFECTION 1
PS PRECOCIOUS PUBERTY VOMITING 1
PS PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ABSCESS STERILE 2
PS PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE INFECTION 2
PS PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 2
PS PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE SWELLING 2
PS PRODUCT USED FOR UNKNOWN INDICATION PAIN 2
PS PRODUCT USED FOR UNKNOWN INDICATION PURULENT DISCHARGE 2
PS PRODUCT USED FOR UNKNOWN INDICATION PYREXIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION VIRAL INFECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 1
PS PUBERTY CHEMICAL INJURY 1
PS PUBERTY GAIT DISTURBANCE 1
PS PUBERTY MUSCLE INJURY 1
PS RESPIRATORY TRACT CONGESTION DIARRHOEA 1
PS RESPIRATORY TRACT CONGESTION PYREXIA 1
PS RESPIRATORY TRACT CONGESTION URINARY TRACT INFECTION 1
PS RESPIRATORY TRACT CONGESTION VIRAL INFECTION 1
PS RESPIRATORY TRACT CONGESTION VOMITING 1
PS VITAMIN SUPPLEMENTATION INJECTION SITE ABSCESS STERILE 1
PS VITAMIN SUPPLEMENTATION INJECTION SITE INFECTION 1
PS VITAMIN SUPPLEMENTATION INJECTION SITE PAIN 1
PS VITAMIN SUPPLEMENTATION INJECTION SITE SWELLING 1
PS VITAMIN SUPPLEMENTATION PAIN 1
PS VITAMIN SUPPLEMENTATION PURULENT DISCHARGE 1
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