Application Nr Approved Date Route Status External Links
ANDA076258 None Transdermal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fentanyl Transdermal System Is A Transdermal Formulation Of Fentanyl Indicated For The Management Of Persistent, Moderate To Severe Chronic Pain In Opioid-Tolerant Patients 2 Years Of Age And Older When A Continuous, Around-The-Clock Opioid Analgesic Is Required For An Extended Period Of Time, And The Patient Cannot Be Managed By Other Means Such As Non-Steroidal Analgesics, Opioid Combination Products, Or Immediate-Release Opioids. Patients Considered Opioid-Tolerant Are Those Who Are Taking At Least 60 Mg Of Morphine Daily, Or At Least 30 Mg Of Oral Oxycodone Daily, Or At Least 8 Mg Of Oral Hydromorphone Daily, Or An Equianalgesic Dose Of Another Opioid For A Week Or Longer. • Fentanyl Transdermal System Contains Fentanyl, A Full Opioid Agonist. • Fentanyl Transdermal System Is Indicated For The Management Of Persistent, Moderate To Severe Chronic Pain In Opioid-Tolerant Patients 2 Years Of Age And Older When A Continuous, Around-The-Clock Opioid Analgesic Is Needed For An Extended Period Of Time. ( 1 ) • Fentanyl Transdermal System Is Not Intended For Use As An As-Needed Analgesic. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fentanyl FENTANYL ZINC2522669

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