Application 020214

Type: NDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEMURON	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ZEMURON	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ZEMURON	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	RLD / RS	Approval date
N020214-001	ZEMURON	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17
N020214-002	ZEMURON	ROCURONIUM BROMIDE	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17
N020214-003	ZEMURON	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020214-002	ZEMURON	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020214-003	ZEMURON	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020214-001	ZEMURON	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1994-03-17	`301d65b070ca…`

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 3 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
rocuronium bromide	ROCURONIUM BROMIDE	XGen Pharmaceuticals DJB, Inc.	b73f192c-2912-4ec3-9b4f-05a58d9b35ba	2022-12-02	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Sandoz Inc	cb28d869-6510-4402-9462-f6bb25fa0fa8	2022-10-13	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	dc444a4b-16ea-568d-e053-2995a90a53a7	2022-04-09	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	209a654d-f92d-4242-bfef-2dcc90a30d3f	2022-01-18	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	818f7cc6-2c3f-1788-e053-2991aa0a4c6a	2021-03-01	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Baxter Healthcare Corporation	31e15c3f-aefa-4379-b684-7707744fe40d	2019-09-30	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE

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
55041	SUPPL	2018-07-30
55025	SUPPL	2018-07-27
34376	SUPPL	2015-01-08
2172	SUPPL	2015-01-08
2171	SUPPL	2010-11-30
34375	SUPPL	2010-11-22
24585	SUPPL	2008-08-29
12321	SUPPL	2008-08-29
52325	SUPPL	2008-04-03
24584	SUPPL	2004-08-25
24582	SUPPL	2004-03-03
24583	SUPPL	2003-06-08
52987	SUPPL	1900-01-01
52986	SUPPL	1900-01-01