Drug information for DURAGESIC-12
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FILM, EXTENDED RELEASE; TRANSDERMAL
12.5MCG/HR
Prescription
AB
FENTANYL
Fentanyl
JANSSEN PHARMS
19813
2010-04-01 Label
2009-11-18 Medication Guide
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2008-02-19 Review
2008-02-14 Label
2008-02-14 Letter
2007-07-09 Review
2007-07-09 Review
2007-07-09 Review
2007-07-09 Review
2005-07-29 Other Important Information from FDA
2005-02-08 Label
2005-02-08 Letter
2003-06-08 Label
2003-06-08 Letter
2001-04-11 Letter
2001-04-11 Letter
Drug Adverse Effects information for DURAGESIC-12
Role code
Indications
Reaction
# Reports
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG DOSE OMISSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INEFFECTIVE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG PRESCRIBING ERROR
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERHIDROSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT PACKAGING QUANTITY ISSUE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT QUALITY ISSUE
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG DOSE OMISSION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
DRUG INEFFECTIVE
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT PACKAGING QUANTITY ISSUE
1
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