FDA.reportPublic FDA data

Application 077449

Type
ANDA
Sponsor
AVEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL-25FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL25MCG/HRNoNo
002FENTANYL-50FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL50MCG/HRNoNo
003FENTANYL-75FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL75MCG/HRNoNo
004FENTANYL-100FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL100MCG/HRNoNo
005FENTANYL-12FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL12.5MCG/HRNoNo
006FENTANYL-37FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL37.5MCG/HRNoNo
007FENTANYL-62FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL62.5MCG/HRNoNo
008FENTANYL-87FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL87.5MCG/HRNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077449-001FENTANYL-25FENTANYL25MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-002FENTANYL-50FENTANYL50MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-003FENTANYL-75FENTANYL75MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-004FENTANYL-100FENTANYL100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20
A077449-005FENTANYL-12FENTANYL12.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11
A077449-006FENTANYL-37FENTANYL37.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06
A077449-007FENTANYL-62FENTANYL62.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06
A077449-008FENTANYL-87FENTANYL87.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A077449-001AB
A077449-002AB
A077449-003AB
A077449-004AB
A077449-005AB
A077449-006AB
A077449-007AB
A077449-008AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0684e616aacf4f…
2026-09-14 22:38:342026-08A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0684e616aacf4f…
2026-08-18 06:07:402026-07A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077449-001FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-002FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-003FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-004FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2008-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-005FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-006FENTANYL-3737.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-007FENTANYL-6262.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-008FENTANYL-8787.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2017-12-066a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 304 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077449-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A077449-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A077449-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077449-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077449-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077449-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077449-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077449-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077449-008AB16a471c1ec25d…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077449
application number: ANDA077449
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077449
application number: ANDA077449

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 149 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-7082FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7082FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7082FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7082FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7083FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7083FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7083FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7083FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7083FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7084FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7084FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7084FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7084FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7084FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7085FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7085FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7085FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7085FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7085FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7086FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7086FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7086FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7086FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7086FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7087FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7087FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7087FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7087FENTANYLFENTANYLApotex Corp.ANDACurrent
60505-7087FENTANYLFENTANYLApotex Corp.ANDACurrent
61919-602FENTANYLFENTANYLDirectRXANDACurrent
61919-602FENTANYLFENTANYLDirectRXANDACurrent
61919-603FENTANYLFENTANYLDirectRXANDACurrent
61919-603FENTANYLFENTANYLDirectRXANDACurrent
63629-4813FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4813FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4813FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4813FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4974FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4974FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4974FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4976FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4976FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
63629-4976FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
68258-3023FentanylFentanylDispensing Solutions Inc.ANDACurrent
68258-3024FentanylFentanylDispensing Solutions Inc.ANDACurrent
68258-3025FentanylFentanylDispensing Solutions Inc.ANDACurrent
71335-0376FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-0376FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-0376FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-0376FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-0376FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1224FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1224FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1224FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1224FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1227FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1227FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1227FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1228FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1228FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1260FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1260FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1260FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1403FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1403FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1403FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1404FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1404FENTANYLFENTANYLBryant Ranch PrepackANDACurrent
71335-1404FENTANYLFENTANYLBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24062ORIG2015-06-30
22605ORIG2014-01-17