Application 020195

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL	FENTANYL CITRATE	TROCHE/LOZENGE;ORAL	EQ 0.2MG BASE	No	No
002	FENTANYL	FENTANYL CITRATE	TROCHE/LOZENGE;ORAL	EQ 0.3MG BASE	No	No
003	FENTANYL	FENTANYL CITRATE	TROCHE/LOZENGE;ORAL	EQ 0.4MG BASE	No	No
007	FENTANYL	FENTANYL CITRATE	TROCHE/LOZENGE;ORAL	EQ 0.1MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N020195-001	FENTANYL	FENTANYL CITRATE	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04
N020195-002	FENTANYL	FENTANYL CITRATE	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04
N020195-003	FENTANYL	FENTANYL CITRATE	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04
N020195-007	FENTANYL	FENTANYL CITRATE	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30

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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020195-001	FENTANYL	EQ 0.2MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020195-002	FENTANYL	EQ 0.3MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020195-003	FENTANYL	EQ 0.4MG BASE	TROCHE/LOZENGE / ORAL	1993-10-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020195-007	FENTANYL	EQ 0.1MG BASE	TROCHE/LOZENGE / ORAL	1995-10-30	`3a93d1ddd44b…`

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 · 11 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 generic name: FENTANYL CITRATE
FENTANYL	FENTANYL	Aveva Drug Delivery Systems Inc.	73897c38-e4ec-40bc-9f41-3359ee23a5a8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL
FENTANYL	FENTANYL	INGENUS PHARMACEUTICALS, LLC	bf02ffd0-cc5d-446b-b648-378f6885052f	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 generic name: FENTANYL CITRATE
FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FENTANYL
Fentanyl Citrate	FENTANYL CITRATE	Fresenius Kabi USA, LLC	0c10e465-4117-48ba-a454-23ccb7a3fcc7	2025-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback 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 generic name: FENTANYL CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41213	SUPPL	1999-08-02