Application 202097

Type: ANDA
Sponsor: 3M DRUG DELIVERY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL-12	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	No	No
002	FENTANYL-25	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	No	No
003	FENTANYL-50	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	No	No
004	FENTANYL-75	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	No	No
005	FENTANYL-100	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202097-001	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-002	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-003	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-004	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-005	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04

Therapeutic equivalence codes#

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

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

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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202097-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202097-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202097-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202097-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-005	AB	1	`2680178bc6a6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fentanyl system	FENTANYL	ALVOGEN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact 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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-423	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-424	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-426	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-427	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
47781-428	Fentanyl System	Fentanyl	Alvogen	ANDA	Current
55700-597	Fentanyl System	Fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-597	Fentanyl System	Fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-597	Fentanyl System	Fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-972	Fentanyl System	Fentanyl	Quality Care Products, LLC	ANDA	Current
55700-973	Fentanyl System	Fentanyl	Quality Care Products, LLC	ANDA	Current

Documents#

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