Application 020630

Type: NDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

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

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

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	RLD / RS	Approval date
N020630-001	ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12
N020630-002	ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12
N020630-003	ULTIVA	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020630-001	AP
N020630-002	AP
N020630-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-002	ULTIVA	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-003	ULTIVA	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020630-001	ULTIVA	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD	1996-07-12	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	N020630-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020630-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020630-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020630-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020630-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020630-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020630-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020630-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020630-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020630-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020630-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020630-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020630-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020630-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020630-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020630-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020630-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020630-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020630-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020630-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020630-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020630-001	AP	1	`1e350fbaab3a…`

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 · 2 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	Exact identifier application applno (NDA): 020630 application number: NDA020630 ndc (product): 67457-914 ndc (product): 67457-912 ndc (product): 67457-913
Ultiva	REMIFENTANIL HYDROCHLORIDE	Mylan Institutional LLC	8b4c8696-e23e-4c51-a4d2-babab5bd945a	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020630 application number: NDA020630

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-198	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-198	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-198	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-198	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-912	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-912	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-913	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-913	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-914	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current
67457-914	Ultiva	Remifentanil Hydrochloride	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84644	SUPPL	2026-01-05
84643	SUPPL	2026-01-05
84600	SUPPL	2025-12-31
84599	SUPPL	2025-12-31
77029	SUPPL	2023-12-19
76954	SUPPL	2023-12-18
60569	SUPPL	2019-10-15
60422	SUPPL	2019-10-09
57681	ORIG	2019-02-15
54746	SUPPL	2018-07-04
46376	SUPPL	2016-12-21
46255	SUPPL	2016-12-20
12873	SUPPL	2004-04-05
25357	SUPPL	2004-03-10