Drug information for GRALISE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
300MG
Prescription
BX (Reference Drug)
GABAPENTIN
gabapentin
DEPOMED INC
22544
2012-02-03 Letter
2012-02-01 Label
2011-10-18 Review
2011-10-18 Summary Review
2011-07-05 Letter
2011-06-30 Label
2011-06-30 Medication Guide
2011-05-03 Letter
2011-03-01 Medication Guide
2011-03-01 Other
2011-02-04 Label
2011-02-03 Letter
TABLET; ORAL
600MG
Prescription
BX (Reference Drug)
GABAPENTIN
gabapentin
DEPOMED INC
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Drug Adverse Effects information for GRALISE
Role code
Indications
Reaction
# Reports
PS
OFF LABEL USE
AGITATION
1
PS
OFF LABEL USE
AMNESIA
1
PS
OFF LABEL USE
CONFUSIONAL STATE
1
PS
OFF LABEL USE
DRY MOUTH
1
PS
OFF LABEL USE
INADEQUATE ANALGESIA
1
PS
PAIN
AGITATION
1
PS
PAIN
AMNESIA
1
PS
PAIN
CONFUSIONAL STATE
1
PS
PAIN
DRY MOUTH
1
PS
PAIN
INADEQUATE ANALGESIA
1
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