Application 076258

Type: ANDA
Sponsor: MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL-25	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	No	No
002	FENTANYL-50	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	No	No
003	FENTANYL-75	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	No	No
004	FENTANYL-100	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	No	No
005	FENTANYL-12	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	No	No
006	FENTANYL-37	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR	No	No
007	FENTANYL-62	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	62.5MCG/HR	No	No
008	FENTANYL-87	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	87.5MCG/HR	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076258-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23
A076258-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29
A076258-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29
A076258-008	FENTANYL-87	FENTANYL	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076258-001	AB
A076258-002	AB
A076258-003	AB
A076258-004	AB
A076258-005	AB
A076258-006	AB
A076258-007	AB
A076258-008	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 9 · 328 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
2026-02-19 14:30 UTC	2026-02	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 317 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076258-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076258-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-008	AB	1	`b8a1b40f171c…`

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	FENTANYL	Mylan Pharmaceuticals Inc.	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076258 application number: ANDA076258 ndc (product): 0378-9127 ndc (product): 0378-9125 ndc (product): 0378-9124 ndc (product): 0378-9119 ndc (product): 0378-9122 ndc (product): 0378-9123 ndc (product): 0378-9121 ndc (product): 0378-9126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-9119	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9119	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9119	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9119	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9121	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9121	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9121	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9121	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9122	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9122	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9122	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9122	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9123	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9123	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9123	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9123	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9124	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9124	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9124	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9124	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9125	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9125	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9125	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9125	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9126	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9126	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9126	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9126	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9127	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9127	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9127	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-9127	FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	ANDA	Current
35356-062	Fentanyl	fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-062	Fentanyl	fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-632	FENTANYL	FENTANYL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-632	FENTANYL	FENTANYL	Quality Care Products, LLC	ANDA	Current
35356-632	FENTANYL	FENTANYL	Quality Care Products, LLC	ANDA	Current
35356-633	FENTANYL	FENTANYL	Quality Care Products, LLC	ANDA	Current
35356-634	FENTANYL	FENTANYL	Quality Care Products, LLC	ANDA	Current
35356-634	FENTANYL	FENTANYL	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-634	FENTANYL	FENTANYL	Quality Care Products, LLC	ANDA	Current
35356-635	Fentanyl	fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-635	Fentanyl	fentanyl	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24053	ORIG	2015-06-30
22551	ORIG	2005-07-22
31105	ORIG	2005-02-01
31104	ORIG	2004-06-24