Application 078907

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.2MG BASE	No	No
002	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.4MG BASE	No	No
003	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.6MG BASE	No	No
004	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 0.8MG BASE	No	No
005	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.2MG BASE	No	No
006	FENTANYL CITRATE	FENTANYL CITRATE	TROCHE/LOZENGE;TRANSMUCOSAL	EQ 1.6MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078907-001	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-002	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-003	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-004	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-005	FENTANYL CITRATE	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30
A078907-006	FENTANYL CITRATE	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30

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 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-005	FENTANYL CITRATE	EQ 1.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078907-006	FENTANYL CITRATE	EQ 1.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078907-001	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078907-002	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078907-003	FENTANYL CITRATE	EQ 0.6MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078907-004	FENTANYL CITRATE	EQ 0.8MG BASE	TROCHE/LOZENGE / TRANSMUCOSAL	2009-10-30	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078907-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078907-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078907-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078907-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078907-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078907-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078907-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078907-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078907-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078907-004	AB	1	`87673890dc5c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL CITRATE generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	ce5db1c2-feb1-4ad2-847a-d02e865bd47e	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Teva Pharmaceuticals USA, Inc.	78221eab-66fd-4cd8-9c81-af52eb83671c	2026-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Civica, Inc.	aacf276b-e133-4199-ad3f-67b894744c04	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Phlow Corp.	58dcd3f7-e3d8-4929-a186-8f680a51ff11	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Hikma Pharmaceuticals USA Inc.	c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	0c10e465-4117-48ba-a454-23ccb7a3fcc7	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	38d0c14a-a0c1-44cc-a939-0304eb8037d6	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fentanyl Citrate generic name: FENTANYL CITRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9204	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9204	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9204	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9204	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9204	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9206	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9206	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9206	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9206	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9206	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9208	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9208	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9208	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9208	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9208	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9212	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9212	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9212	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9212	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9212	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9216	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9216	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9216	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9216	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current
0406-9216	FENTANYL CITRATE	FENTANYL CITRATE	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44540	ORIG	2012-02-03
31397	ORIG	2009-11-05
43897	ORIG	2009-11-04