FDA.reportPublic FDA data

Application 202097

Type
ANDA
Sponsor
3M DRUG DELIVERY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL-12FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL12.5MCG/HRNoNo
002FENTANYL-25FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL25MCG/HRNoNo
003FENTANYL-50FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL50MCG/HRNoNo
004FENTANYL-75FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL75MCG/HRNoNo
005FENTANYL-100FENTANYLFILM, EXTENDED RELEASE;TRANSDERMAL100MCG/HRNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202097-001FENTANYL-12FENTANYL12.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-002FENTANYL-25FENTANYL25MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-003FENTANYL-50FENTANYL50MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-004FENTANYL-75FENTANYL75MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-005FENTANYL-100FENTANYL100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202097-001AB
A202097-002AB
A202097-003AB
A202097-004AB
A202097-005AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202097-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A202097-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202097
application number: ANDA202097
ndc (product): 47781-426
ndc (product): 47781-428
ndc (product): 47781-424
ndc (product): 47781-423
ndc (product): 47781-427

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-423Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-424Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-426Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-427Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
47781-428Fentanyl SystemFentanylAlvogenANDACurrent
55700-597Fentanyl SystemFentanylLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-597Fentanyl SystemFentanylLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-597Fentanyl SystemFentanylLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-972Fentanyl SystemFentanylQuality Care Products, LLCANDACurrent
55700-973Fentanyl SystemFentanylQuality Care Products, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76221ORIG 2023-11-03