Drug information for ROBINUL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 0.2MG/ML Discontinued   GLYCOPYRROLATE Glycopyrrolate ROBINS AH 14764
INJECTABLE; INJECTION 0.2MG/ML Prescription AP (Reference Drug) GLYCOPYRROLATE Glycopyrrolate BAXTER HLTHCARE 17558
2007-02-20 Review

2005-05-27 Label

2005-05-27 Letter

2004-11-08 Letter

2004-11-08 Letter

2004-11-08 Letter

2004-11-08 Letter

2003-07-06 Letter

2003-07-06 Letter
TABLET; ORAL 1MG Prescription AA (Reference Drug) GLYCOPYRROLATE Glycopyrrolate SHIONOGI INC 12827
2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2009-09-14 Review

2003-08-06 Letter

Drug Adverse Effects information for ROBINUL

Role code Indications Reaction # Reports
C ACNE BLOOD CHOLESTEROL INCREASED 1
C ACNE CHOLECYSTITIS CHRONIC 1
C ACNE GALLBLADDER DISORDER 1
C ACNE INJURY 1
C ACNE KIDNEY INFECTION 1
C ACNE NEPHROLITHIASIS 1
C ACNE PAIN 1
C ACNE RENAL INJURY 1
C ACUTE CORONARY SYNDROME CARDIAC DEATH 1
C ACUTE CORONARY SYNDROME DRUG INEFFECTIVE 1
C ACUTE CORONARY SYNDROME THROMBOSIS IN DEVICE 1
C ANTIPLATELET THERAPY CARDIAC DEATH 1
C ANTIPLATELET THERAPY DRUG INEFFECTIVE 1
C ANTIPLATELET THERAPY THROMBOSIS IN DEVICE 1
C ANXIETY DRUG DISPENSING ERROR 2
C ANXIETY DYSTONIA 2
C ANXIETY HALLUCINATION 2
C ANXIETY LOCKED-IN SYNDROME 2
C ANXIETY NIGHTMARE 2
C ANXIETY PARALYSIS 2
C ANXIETY TARDIVE DYSKINESIA 2
C ANXIETY TREMOR 2
C AORTIC VALVE REPAIR ANHEDONIA 2
C AORTIC VALVE REPAIR ANXIETY 2
C AORTIC VALVE REPAIR EMOTIONAL DISTRESS 2
C AORTIC VALVE REPAIR FEAR 2
C AORTIC VALVE REPAIR INJURY 2
C AORTIC VALVE REPAIR PAIN 2
C AORTIC VALVE REPAIR RENAL FAILURE 2
C AORTIC VALVE REPAIR RENAL IMPAIRMENT 2
C AORTIC VALVE REPAIR RENAL INJURY 2
C AORTIC VALVE REPAIR STRESS 2
C AORTIC VALVE REPAIR UNEVALUABLE EVENT 2
C BLOOD PRESSURE DECREASED ANGIOEDEMA 1
C BLOOD PRESSURE DECREASED BRAIN DEATH 1
C BLOOD PRESSURE DECREASED CARDIO-RESPIRATORY ARREST 1
C BLOOD PRESSURE DECREASED HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1
C BLOOD PRESSURE DECREASED SPINAL OSTEOARTHRITIS 1
C BRONCHITIS EPICONDYLITIS 1
C BRONCHITIS ROTATOR CUFF SYNDROME 1
C BRONCHITIS TENDON RUPTURE 1
C CHEST PAIN ANXIETY 1
C CHEST PAIN EMOTIONAL DISTRESS 1
C CHEST PAIN FEAR 1
C CHEST PAIN INJURY 1
C CHEST PAIN PAIN 1
C CHEST PAIN PSYCHOLOGICAL TRAUMA 1
C CHEST PAIN RENAL FAILURE 1
C CHEST PAIN RENAL IMPAIRMENT 1
C CHEST PAIN RENAL INJURY 1
C CHEST PAIN STRESS 1
C CHEST PAIN UNEVALUABLE EVENT 1
C CONTRACEPTION ABDOMINAL PAIN UPPER 2
C CONTRACEPTION CHEST PAIN 2
C CONTRACEPTION CHOLECYSTITIS 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION DIARRHOEA 2
C CONTRACEPTION GALLBLADDER CHOLESTEROLOSIS 1
C CONTRACEPTION GALLBLADDER DISORDER 2
C CONTRACEPTION HYPERTENSION 2
C CONTRACEPTION NAUSEA 2
C CORONARY ARTERY BYPASS ANHEDONIA 2
C CORONARY ARTERY BYPASS ANXIETY 3
C CORONARY ARTERY BYPASS EMOTIONAL DISTRESS 3
C CORONARY ARTERY BYPASS FEAR 3
C CORONARY ARTERY BYPASS INJURY 3
C CORONARY ARTERY BYPASS PAIN 3
C CORONARY ARTERY BYPASS PSYCHOLOGICAL TRAUMA 1
C CORONARY ARTERY BYPASS RENAL FAILURE 3
C CORONARY ARTERY BYPASS RENAL IMPAIRMENT 3
C CORONARY ARTERY BYPASS RENAL INJURY 3
C CORONARY ARTERY BYPASS STRESS 3
C CORONARY ARTERY BYPASS UNEVALUABLE EVENT 3
C DYSMENORRHOEA ABDOMINAL PAIN UPPER 2
C DYSMENORRHOEA CHOLECYSTITIS CHRONIC 2
C DYSMENORRHOEA CHOLELITHIASIS 2
C DYSMENORRHOEA DIARRHOEA 2
C DYSMENORRHOEA GASTROOESOPHAGEAL REFLUX DISEASE 2
C DYSMENORRHOEA INJURY 2
C DYSMENORRHOEA PAIN 2
C DYSMENORRHOEA POST PROCEDURAL DIARRHOEA 2
C GASTRITIS ABDOMINAL PAIN 1
C GASTRITIS BILIARY DYSKINESIA 1
C GASTRITIS CHOLECYSTECTOMY 1
C GASTRITIS CHOLECYSTITIS CHRONIC 1
C GASTRITIS DEPRESSION 1
C GASTRITIS EMOTIONAL DISTRESS 1
C GASTRITIS FEAR 1
C GASTRITIS NERVOUSNESS 1
C GASTRITIS PAIN 1
C GASTROOESOPHAGEAL REFLUX DISEASE ABDOMINAL PAIN UPPER 4
C GASTROOESOPHAGEAL REFLUX DISEASE CHOLECYSTITIS CHRONIC 4
C GASTROOESOPHAGEAL REFLUX DISEASE CHOLELITHIASIS 4
C GASTROOESOPHAGEAL REFLUX DISEASE DIARRHOEA 4
C GASTROOESOPHAGEAL REFLUX DISEASE EPICONDYLITIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 4
C GASTROOESOPHAGEAL REFLUX DISEASE INJURY 4
C GASTROOESOPHAGEAL REFLUX DISEASE PAIN 4
C GASTROOESOPHAGEAL REFLUX DISEASE POST PROCEDURAL DIARRHOEA 4
C GASTROOESOPHAGEAL REFLUX DISEASE ROTATOR CUFF SYNDROME 1
C GASTROOESOPHAGEAL REFLUX DISEASE TENDON RUPTURE 1
C HYPERHIDROSIS EPICONDYLITIS 1
C HYPERHIDROSIS ROTATOR CUFF SYNDROME 1
C HYPERHIDROSIS TENDON RUPTURE 1
C HYPERTENSION EPICONDYLITIS 1
C HYPERTENSION ROTATOR CUFF SYNDROME 1
C HYPERTENSION TENDON RUPTURE 1
C HYPOTHYROIDISM DRUG DISPENSING ERROR 2
C HYPOTHYROIDISM DYSTONIA 2
C HYPOTHYROIDISM HALLUCINATION 2
C HYPOTHYROIDISM LOCKED-IN SYNDROME 2
C HYPOTHYROIDISM NIGHTMARE 2
C HYPOTHYROIDISM PARALYSIS 2
C HYPOTHYROIDISM TARDIVE DYSKINESIA 2
C HYPOTHYROIDISM TREMOR 2
C IRRITABLE BOWEL SYNDROME ABDOMINAL PAIN 1
C IRRITABLE BOWEL SYNDROME ABDOMINAL PAIN UPPER 2
C IRRITABLE BOWEL SYNDROME BILIARY DYSKINESIA 1
C IRRITABLE BOWEL SYNDROME CHOLECYSTECTOMY 1
C IRRITABLE BOWEL SYNDROME CHOLECYSTITIS CHRONIC 3
C IRRITABLE BOWEL SYNDROME CHOLELITHIASIS 2
C IRRITABLE BOWEL SYNDROME DEPRESSION 1
C IRRITABLE BOWEL SYNDROME DIARRHOEA 2
C IRRITABLE BOWEL SYNDROME EMOTIONAL DISTRESS 1
C IRRITABLE BOWEL SYNDROME FEAR 1
C IRRITABLE BOWEL SYNDROME GASTROOESOPHAGEAL REFLUX DISEASE 2
C IRRITABLE BOWEL SYNDROME INJURY 2
C IRRITABLE BOWEL SYNDROME NERVOUSNESS 1
C IRRITABLE BOWEL SYNDROME PAIN 3
C IRRITABLE BOWEL SYNDROME POST PROCEDURAL DIARRHOEA 2
C LEUKAEMIA DRUG DISPENSING ERROR 2
C LEUKAEMIA DYSTONIA 2
C LEUKAEMIA HALLUCINATION 2
C LEUKAEMIA LOCKED-IN SYNDROME 2
C LEUKAEMIA NIGHTMARE 2
C LEUKAEMIA PARALYSIS 2
C LEUKAEMIA TARDIVE DYSKINESIA 2
C LEUKAEMIA TREMOR 2
C MENORRHAGIA ABDOMINAL PAIN 1
C MENORRHAGIA ABDOMINAL PAIN UPPER 2
C MENORRHAGIA BILIARY DYSKINESIA 1
C MENORRHAGIA CHOLECYSTECTOMY 1
C MENORRHAGIA CHOLECYSTITIS CHRONIC 3
C MENORRHAGIA CHOLELITHIASIS 2
C MENORRHAGIA DEPRESSION 1
C MENORRHAGIA DIARRHOEA 2
C MENORRHAGIA EMOTIONAL DISTRESS 1
C MENORRHAGIA FEAR 1
C MENORRHAGIA GASTROOESOPHAGEAL REFLUX DISEASE 2
C MENORRHAGIA INJURY 2
C MENORRHAGIA NERVOUSNESS 1
C MENORRHAGIA PAIN 3
C MENORRHAGIA POST PROCEDURAL DIARRHOEA 2
C MENSTRUAL CYCLE MANAGEMENT ABDOMINAL PAIN 1
C MENSTRUAL CYCLE MANAGEMENT ABDOMINAL PAIN UPPER 2
C MENSTRUAL CYCLE MANAGEMENT BILIARY DYSKINESIA 1
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTECTOMY 1
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS CHRONIC 3
C MENSTRUAL CYCLE MANAGEMENT CHOLELITHIASIS 2
C MENSTRUAL CYCLE MANAGEMENT DEPRESSION 1
C MENSTRUAL CYCLE MANAGEMENT DIARRHOEA 2
C MENSTRUAL CYCLE MANAGEMENT EMOTIONAL DISTRESS 1
C MENSTRUAL CYCLE MANAGEMENT FEAR 1
C MENSTRUAL CYCLE MANAGEMENT GASTROOESOPHAGEAL REFLUX DISEASE 2
C MENSTRUAL CYCLE MANAGEMENT INJURY 2
C MENSTRUAL CYCLE MANAGEMENT NERVOUSNESS 1
C MENSTRUAL CYCLE MANAGEMENT PAIN 3
C MENSTRUAL CYCLE MANAGEMENT POST PROCEDURAL DIARRHOEA 2
C MENSTRUATION IRREGULAR CHOLECYSTITIS CHRONIC 2
C MENSTRUATION IRREGULAR CHOLELITHIASIS 2
C MENSTRUATION IRREGULAR GALLBLADDER DISORDER 2
C MENSTRUATION IRREGULAR GALLBLADDER NON-FUNCTIONING 2
C MENSTRUATION IRREGULAR INJURY 2
C MENSTRUATION IRREGULAR PAIN 2
C MIGRAINE ABDOMINAL PAIN 1
C MIGRAINE BILIARY DYSKINESIA 1
C MIGRAINE BLOOD CHOLESTEROL INCREASED 1
C MIGRAINE CHOLECYSTECTOMY 1
C MIGRAINE CHOLECYSTITIS CHRONIC 2
C MIGRAINE DEPRESSION 1
C MIGRAINE EMOTIONAL DISTRESS 1
C MIGRAINE FEAR 1
C MIGRAINE GALLBLADDER DISORDER 1
C MIGRAINE INJURY 1
C MIGRAINE KIDNEY INFECTION 1
C MIGRAINE NEPHROLITHIASIS 1
C MIGRAINE NERVOUSNESS 1
C MIGRAINE PAIN 2
C MIGRAINE RENAL INJURY 1
C MIGRAINE PROPHYLAXIS ABDOMINAL PAIN 1
C MIGRAINE PROPHYLAXIS BILIARY DYSKINESIA 1
C MIGRAINE PROPHYLAXIS CHOLECYSTECTOMY 1
C MIGRAINE PROPHYLAXIS CHOLECYSTITIS CHRONIC 1
C MIGRAINE PROPHYLAXIS DEPRESSION 1
C MIGRAINE PROPHYLAXIS EMOTIONAL DISTRESS 1
C MIGRAINE PROPHYLAXIS FEAR 1
C MIGRAINE PROPHYLAXIS NERVOUSNESS 1
C MIGRAINE PROPHYLAXIS PAIN 1
C MULTIPLE ALLERGIES ABDOMINAL PAIN UPPER 2
C MULTIPLE ALLERGIES CHEST PAIN 2
C MULTIPLE ALLERGIES CHOLECYSTITIS 1
C MULTIPLE ALLERGIES CHOLECYSTITIS CHRONIC 1
C MULTIPLE ALLERGIES CHOLELITHIASIS 1
C MULTIPLE ALLERGIES DIARRHOEA 2
C MULTIPLE ALLERGIES GALLBLADDER CHOLESTEROLOSIS 1
C MULTIPLE ALLERGIES GALLBLADDER DISORDER 2
C MULTIPLE ALLERGIES HYPERTENSION 2
C MULTIPLE ALLERGIES NAUSEA 2
C ORAL CONTRACEPTION CHOLECYSTITIS CHRONIC 2
C ORAL CONTRACEPTION CHOLELITHIASIS 2
C ORAL CONTRACEPTION GALLBLADDER DISORDER 2
C ORAL CONTRACEPTION GALLBLADDER NON-FUNCTIONING 2
C ORAL CONTRACEPTION INJURY 2
C ORAL CONTRACEPTION PAIN 2
C OVARIAN CYST BLOOD CHOLESTEROL INCREASED 1
C OVARIAN CYST CHOLECYSTITIS CHRONIC 1
C OVARIAN CYST GALLBLADDER DISORDER 1
C OVARIAN CYST INJURY 1
C OVARIAN CYST KIDNEY INFECTION 1
C OVARIAN CYST NEPHROLITHIASIS 1
C OVARIAN CYST PAIN 1
C OVARIAN CYST RENAL INJURY 1
C PAIN ABDOMINAL PAIN UPPER 2
C PAIN CHEST PAIN 2
C PAIN CHOLECYSTITIS 1
C PAIN CHOLECYSTITIS CHRONIC 1
C PAIN CHOLELITHIASIS 1
C PAIN DIARRHOEA 2
C PAIN GALLBLADDER CHOLESTEROLOSIS 1
C PAIN GALLBLADDER DISORDER 2
C PAIN HYPERTENSION 2
C PAIN NAUSEA 2
C PARKINSON'S DISEASE DRUG DISPENSING ERROR 6
C PARKINSON'S DISEASE DYSTONIA 6
C PARKINSON'S DISEASE HALLUCINATION 6
C PARKINSON'S DISEASE LOCKED-IN SYNDROME 6
C PARKINSON'S DISEASE NIGHTMARE 6
C PARKINSON'S DISEASE PARALYSIS 6
C PARKINSON'S DISEASE TARDIVE DYSKINESIA 6
C PARKINSON'S DISEASE TREMOR 6
C PREMENSTRUAL SYNDROME ABDOMINAL PAIN 1
C PREMENSTRUAL SYNDROME ABDOMINAL PAIN UPPER 2
C PREMENSTRUAL SYNDROME BILIARY DYSKINESIA 1
C PREMENSTRUAL SYNDROME BLOOD CHOLESTEROL INCREASED 1
C PREMENSTRUAL SYNDROME CHOLECYSTECTOMY 1
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 4
C PREMENSTRUAL SYNDROME CHOLELITHIASIS 2
C PREMENSTRUAL SYNDROME DEPRESSION 1
C PREMENSTRUAL SYNDROME DIARRHOEA 2
C PREMENSTRUAL SYNDROME EMOTIONAL DISTRESS 1
C PREMENSTRUAL SYNDROME FEAR 1
C PREMENSTRUAL SYNDROME GALLBLADDER DISORDER 1
C PREMENSTRUAL SYNDROME GASTROOESOPHAGEAL REFLUX DISEASE 2
C PREMENSTRUAL SYNDROME INJURY 3
C PREMENSTRUAL SYNDROME KIDNEY INFECTION 1
C PREMENSTRUAL SYNDROME NEPHROLITHIASIS 1
C PREMENSTRUAL SYNDROME NERVOUSNESS 1
C PREMENSTRUAL SYNDROME PAIN 4
C PREMENSTRUAL SYNDROME POST PROCEDURAL DIARRHOEA 2
C PREMENSTRUAL SYNDROME RENAL INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG DISPENSING ERROR 2
C PRODUCT USED FOR UNKNOWN INDICATION DYSTONIA 2
C PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 2
C PRODUCT USED FOR UNKNOWN INDICATION LOCKED-IN SYNDROME 2
C PRODUCT USED FOR UNKNOWN INDICATION NIGHTMARE 2
C PRODUCT USED FOR UNKNOWN INDICATION PARALYSIS 2
C PRODUCT USED FOR UNKNOWN INDICATION TARDIVE DYSKINESIA 2
C PRODUCT USED FOR UNKNOWN INDICATION TREMOR 2
C RESTLESS LEGS SYNDROME DRUG DISPENSING ERROR 2
C RESTLESS LEGS SYNDROME DYSTONIA 2
C RESTLESS LEGS SYNDROME HALLUCINATION 2
C RESTLESS LEGS SYNDROME LOCKED-IN SYNDROME 2
C RESTLESS LEGS SYNDROME NIGHTMARE 2
C RESTLESS LEGS SYNDROME PARALYSIS 2
C RESTLESS LEGS SYNDROME TARDIVE DYSKINESIA 2
C RESTLESS LEGS SYNDROME TREMOR 2
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