Application 215635

Type: ANDA
Sponsor: NIVAGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	No	No
002	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/VIAL	No	No
003	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215635-001	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28
A215635-002	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28
A215635-003	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215635-001	AP
A215635-002	AP
A215635-003	AP

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 2 · 45 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
2026-09-14 22:38:34	2026-08	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215635-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215635-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215635-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-06-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215635-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215635-003	AP	1	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215635-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215635-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215635-003	AP	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultiva	REMIFENTANIL HYDROCHLORIDE	Mylan Institutional LLC	4dbcb8f9-1987-4b66-bd2f-d251fda0be10	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: REMIFENTANIL HYDROCHLORIDE
Ultiva	REMIFENTANIL HYDROCHLORIDE	Mylan Institutional LLC	8b4c8696-e23e-4c51-a4d2-babab5bd945a	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: REMIFENTANIL HYDROCHLORIDE
Remifentanil Hydrochloride	REMIFENTANIL HYDROCHLORIDE	Fresenius Kabi USA, LLC	5b8025d2-3424-477b-9cff-3990a98c2a65	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Remifentanil Hydrochloride generic name: REMIFENTANIL HYDROCHLORIDE
Remifentanil Hydrochloride	REMIFENTANIL HYDROCHLORIDE	Fresenius Kabi USA, LLC	d2374b84-81c9-44f9-a4a9-1071281b2531	2024-09-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Remifentanil Hydrochloride generic name: REMIFENTANIL HYDROCHLORIDE
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: REMIFENTANIL HYDROCHLORIDE generic name: REMIFENTANIL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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