Drug information for ABSTRAL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; SUBLINGUAL EQ 0.1MG BASE Prescription   FENTANYL CITRATE Fentanyl PROSTRAKAN INC 22510
2012-01-06 Label
2012-01-03 Letter
2011-11-02 Review
2011-11-02 Summary Review
2011-01-14 Other
2011-01-14 Letter
2011-01-13 Medication Guide
2011-01-10 Label
TABLET; SUBLINGUAL EQ 0.2MG BASE Prescription   FENTANYL CITRATE Fentanyl PROSTRAKAN INC   "
TABLET; SUBLINGUAL EQ 0.3MG BASE Prescription   FENTANYL CITRATE Fentanyl PROSTRAKAN INC   "
TABLET; SUBLINGUAL EQ 0.4MG BASE Prescription  (Reference Drug) FENTANYL CITRATE Fentanyl PROSTRAKAN INC   "
TABLET; SUBLINGUAL EQ 0.6MG BASE Prescription   FENTANYL CITRATE Fentanyl PROSTRAKAN INC   "
TABLET; SUBLINGUAL EQ 0.8MG BASE Prescription   FENTANYL CITRATE Fentanyl PROSTRAKAN INC   "

Drug Adverse Effects information for ABSTRAL

Role code Indications Reaction # Reports
PS BACK PAIN BREAKTHROUGH PAIN 1
PS BACK PAIN MULTIPLE DRUG OVERDOSE 1
PS BACK PAIN NEUROLOGICAL SYMPTOM 1
PS BACK PAIN OFF LABEL USE 1
PS BACK PAIN SOMNOLENCE 1
PS BACK PAIN TOXICITY TO VARIOUS AGENTS 1
PS BREAKTHROUGH PAIN DRUG INEFFECTIVE 1
PS BREAKTHROUGH PAIN INTENTIONAL DRUG MISUSE 2
PS BREAKTHROUGH PAIN NO ADVERSE EVENT 2
PS BREAKTHROUGH PAIN OFF LABEL USE 1
PS BREAKTHROUGH PAIN PRODUCT QUALITY ISSUE 1
PS PAIN BREAKTHROUGH PAIN 2
PS PAIN MULTIPLE DRUG OVERDOSE 2
PS PAIN NEUROLOGICAL SYMPTOM 2
PS PAIN OFF LABEL USE 2
PS PAIN SOMNOLENCE 2
PS PAIN TOXICITY TO VARIOUS AGENTS 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 1
SS BREAKTHROUGH PAIN INTENTIONAL DRUG MISUSE 2
SS BREAKTHROUGH PAIN NO ADVERSE EVENT 2
SS PAIN DRUG INEFFECTIVE 7
SS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 4
SS PAIN NEUROLOGICAL SYMPTOM 3
SS PAIN OVERDOSE 3
SS PAIN SOMNOLENCE 3
SS PAIN TOXICITY TO VARIOUS AGENTS 3
SS PAIN TREATMENT NONCOMPLIANCE 4
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 3
SS PRODUCT USED FOR UNKNOWN INDICATION NEUROLOGICAL SYMPTOM 3
SS PRODUCT USED FOR UNKNOWN INDICATION OVERDOSE 3
SS PRODUCT USED FOR UNKNOWN INDICATION SOMNOLENCE 3
SS PRODUCT USED FOR UNKNOWN INDICATION TOXICITY TO VARIOUS AGENTS 3
C DIABETES MELLITUS MUSCULAR WEAKNESS 1
C DIABETES MELLITUS TUMOUR PAIN 1
C HYPOTENSION MUSCULAR WEAKNESS 2
C HYPOTENSION TUMOUR PAIN 2
C PROSTATE CANCER METASTATIC MUSCULAR WEAKNESS 2
C PROSTATE CANCER METASTATIC TUMOUR PAIN 2
C TUMOUR PAIN MUSCULAR WEAKNESS 4
C TUMOUR PAIN TUMOUR PAIN 4
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