Application 207338

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.1MG BASE	No	No
002	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.2MG BASE	No	No
003	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.3MG BASE	No	No
004	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.4MG BASE	No	No
005	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.6MG BASE	No	No
006	FENTANYL CITRATE	FENTANYL CITRATE	TABLET;SUBLINGUAL	EQ 0.8MG 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207338-001	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17
A207338-002	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17
A207338-003	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17
A207338-004	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17
A207338-005	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17
A207338-006	FENTANYL CITRATE	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17

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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207338-005	FENTANYL CITRATE	EQ 0.6MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207338-006	FENTANYL CITRATE	EQ 0.8MG BASE	TABLET / SUBLINGUAL	2017-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207338-001	FENTANYL CITRATE	EQ 0.1MG BASE	TABLET / SUBLINGUAL	2017-11-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207338-002	FENTANYL CITRATE	EQ 0.2MG BASE	TABLET / SUBLINGUAL	2017-11-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207338-003	FENTANYL CITRATE	EQ 0.3MG BASE	TABLET / SUBLINGUAL	2017-11-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207338-004	FENTANYL CITRATE	EQ 0.4MG BASE	TABLET / SUBLINGUAL	2017-11-17	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A207338-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207338-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207338-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207338-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207338-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207338-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207338-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207338-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207338-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207338-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207338-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207338-006	AB	1	`ea99ee380514…`

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 · 8 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	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

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
76276	ORIG	2023-11-03
50731	ORIG	2017-12-18