Application 077154

Type: ANDA
Sponsor: SPECGX LLC

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

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077154-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09
A077154-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11
A077154-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14
A077154-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A077154-001	AB
A077154-002	AB
A077154-003	AB
A077154-004	AB
A077154-005	AB
A077154-006	AB
A077154-007	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 7 · 279 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 279 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	A077154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077154-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077154-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077154-005	AB	1	`03ed91905a0d…`

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 TRANSDERMAL	FENTANYL TRANSDERMAL	SpecGx LLC	e15a7e9b-8025-49dd-9a6d-bafcccf1959f	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077154 application number: ANDA077154 ndc (product): 0406-9112 ndc (product): 0406-9037 ndc (product): 0406-9100 ndc (product): 0406-9062 ndc (product): 0406-9150 ndc (product): 0406-9125 ndc (product): 0406-9175

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-9000	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9000	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9000	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9000	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	SpecGx LLC	ANDA	Current
0406-9000	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9000	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9012	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9025	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9037	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9037	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9037	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9050	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9062	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9062	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9062	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9075	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9100	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9100	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9112	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9112	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9125	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9125	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9150	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9150	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9175	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
0406-9175	FENTANYL TRANSDERMAL	fentanyl transdermal	SpecGx LLC	ANDA	Current
21695-975	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Rebel Distributors Corp	ANDA	Current
35356-637	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-638	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-638	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42254-002	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Rebel Distributors Corp.	ANDA	Current
63629-4764	FENTANYL TRANSDERMAL	fentanyl transdermal	Bryant Ranch Prepack	ANDA	Current
63629-4764	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-4771	FENTANYL TRANSDERMAL	fentanyl transdermal	Bryant Ranch Prepack	ANDA	Current
63629-4771	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal	Bryant Ranch Prepack	ANDA	Current
63629-4771	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-4773	FENTANYL TRANSDERMAL	fentanyl transdermal	Bryant Ranch Prepack	ANDA	Current
63629-4773	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current
63629-5492	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current
71335-0683	FENTANYL TRANSDERMAL system	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current
71335-0683	FENTANYL TRANSDERMAL SYSTEM	fentanyl transdermal system	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24060	ORIG	2015-06-30