Drug information for LABETALOL HYDROCHLORIDE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 5MG/ML Prescription AP (Reference Drug) LABETALOL HYDROCHLORIDE Labetalol HOSPIRA 75239
2004-06-08 Letter
INJECTABLE; INJECTION 5MG/ML Prescription AP (Reference Drug) LABETALOL HYDROCHLORIDE Labetalol HOSPIRA 75240
2004-06-08 Letter
2004-06-08 Letter
INJECTABLE; INJECTION 5MG/ML Discontinued   LABETALOL HYDROCHLORIDE Labetalol HOSPIRA 75242
2004-06-08 Letter
2004-06-08 Letter
INJECTABLE; INJECTION 5MG/ML Prescription AP  LABETALOL HYDROCHLORIDE Labetalol BEDFORD 75303
1999-05-28 Letter
INJECTABLE; INJECTION 5MG/ML Discontinued   LABETALOL HYDROCHLORIDE Labetalol APOTHECON 75355
1999-12-29 Letter
INJECTABLE; INJECTION 5MG/ML Prescription AP  LABETALOL HYDROCHLORIDE Labetalol TAYLOR 75431
1999-12-29 Letter
INJECTABLE; INJECTION 5MG/ML Prescription AP  LABETALOL HYDROCHLORIDE Labetalol TAYLOR 75524
1999-11-29 Letter
INJECTABLE; INJECTION 5MG/ML Prescription AP  LABETALOL HYDROCHLORIDE Labetalol CLARIS LIFESCIENCES 76051
INJECTABLE; INJECTION 5MG/ML Prescription AP  LABETALOL HYDROCHLORIDE Labetalol GLAND PHARMA LTD 90699
TABLET; ORAL 100MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol IVAX SUB TEVA PHARMS 74787
2004-06-08 Label
2003-08-01 Review
1998-08-03 Letter
TABLET; ORAL 200MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol IVAX SUB TEVA PHARMS   "
TABLET; ORAL 300MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol IVAX SUB TEVA PHARMS   "
TABLET; ORAL 100MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol TEVA 74989
2002-09-25 Review
1998-09-30 Letter
TABLET; ORAL 200MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol TEVA   "
TABLET; ORAL 300MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol TEVA   "
TABLET; ORAL 100MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol SANDOZ 75113
1998-08-04 Letter
TABLET; ORAL 200MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol SANDOZ   "
TABLET; ORAL 300MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol SANDOZ   "
TABLET; ORAL 100MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol WATSON LABS 75133
2002-09-25 Review
1998-08-03 Letter
TABLET; ORAL 200MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol WATSON LABS   "
TABLET; ORAL 300MG Prescription AB  LABETALOL HYDROCHLORIDE Labetalol WATSON LABS   "
TABLET; ORAL 100MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol MUTUAL PHARM 75215
1999-07-29 Letter
TABLET; ORAL 200MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol MUTUAL PHARM   "
TABLET; ORAL 300MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol MUTUAL PHARM   "
TABLET; ORAL 100MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol APOTHECON 75223
1998-11-23 Letter
TABLET; ORAL 200MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol APOTHECON   "
TABLET; ORAL 300MG Discontinued   LABETALOL HYDROCHLORIDE Labetalol APOTHECON   "

Drug Adverse Effects information for LABETALOL HYDROCHLORIDE

Role code Indications Reaction # Reports
PS HYPERTENSION CIRCULATORY COLLAPSE 3
PS HYPERTENSION LOSS OF CONSCIOUSNESS 3
PS HYPERTENSION NO THERAPEUTIC RESPONSE 3
PS HYPERTENSION PHAEOCHROMOCYTOMA 3
PS HYPERTENSION TACHYCARDIA 3
PS HYPERTENSION VENTRICULAR FIBRILLATION 3
C ANXIETY ACUTE MYOCARDIAL INFARCTION 1
C ANXIETY CARDIO-RESPIRATORY ARREST 1
C ANXIETY HOSPITALISATION 1
C ANXIETY HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1
C ANXIETY LUNG NEOPLASM MALIGNANT 1
C ANXIETY RENAL FAILURE CHRONIC 1
C CHRONIC MYELOID LEUKAEMIA BACK PAIN 1
C CHRONIC MYELOID LEUKAEMIA BLOOD BILIRUBIN INCREASED 1
C CHRONIC MYELOID LEUKAEMIA BLOOD CREATININE INCREASED 1
C CHRONIC MYELOID LEUKAEMIA BLOOD POTASSIUM INCREASED 1
C CHRONIC MYELOID LEUKAEMIA DRY SKIN 1
C CHRONIC MYELOID LEUKAEMIA DYSPNOEA 2
C CHRONIC MYELOID LEUKAEMIA FATIGUE 1
C CHRONIC MYELOID LEUKAEMIA MUSCLE SPASMS 1
C CHRONIC MYELOID LEUKAEMIA NAUSEA 1
C CHRONIC MYELOID LEUKAEMIA PRURITUS 2
C CHRONIC MYELOID LEUKAEMIA RASH 2
C CHRONIC MYELOID LEUKAEMIA VOMITING 1
C DIALYSIS ANAEMIA 1
C DIALYSIS APLASIA PURE RED CELL 1
C DIALYSIS EPISTAXIS 1
C DIALYSIS MALNUTRITION 1
C DIALYSIS NEUTROPENIA 1
C LIVER TRANSPLANT ACUTE MYOCARDIAL INFARCTION 1
C LIVER TRANSPLANT CARDIO-RESPIRATORY ARREST 1
C LIVER TRANSPLANT HOSPITALISATION 1
C LIVER TRANSPLANT HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 1
C LIVER TRANSPLANT LUNG NEOPLASM MALIGNANT 1
C LIVER TRANSPLANT RENAL FAILURE CHRONIC 1
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE MYOCARDIAL INFARCTION 16
C PRODUCT USED FOR UNKNOWN INDICATION CAESAREAN SECTION 11
C PRODUCT USED FOR UNKNOWN INDICATION CARDIO-RESPIRATORY ARREST 16
C PRODUCT USED FOR UNKNOWN INDICATION HOSPITALISATION 16
C PRODUCT USED FOR UNKNOWN INDICATION HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 16
C PRODUCT USED FOR UNKNOWN INDICATION LUNG NEOPLASM MALIGNANT 16
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE CHRONIC 16
C TYPE 2 DIABETES MELLITUS BLOOD CREATININE INCREASED 1
C TYPE 2 DIABETES MELLITUS RENAL FAILURE ACUTE 1
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