Application 217034

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	50MG/5ML (10MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217034-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION			2023-05-24

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2023-05-24	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217034-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2023-05-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

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	A217034-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217034-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217034-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217034-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217034-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217034-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217034-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217034-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217034-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217034-001	AP	1	`3f0d92c62455…`

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	Shandong New Time Pharmaceutical Co., Ltd.	f9f66e17-4850-47b6-bb2c-b9d126dffa68	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	ProPharma Distribution	579c4dfd-4877-33bb-e063-6394a90ae3d9	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	B. Braun Medical Inc.	a54a79f7-5207-43d8-a139-7d57557caa50	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Eugia US LLC	116385ea-69fc-4f44-b463-6210291032df	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	4f9bf2d0-5702-4610-e063-6294a90a2cd9	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	Hospira, Inc.	cccd40ca-5f08-4acb-8548-3cad558388bb	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Hospira, Inc.	309aeb1b-8022-4df7-8194-ae6529e3395c	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Meitheal Pharmaceuticals Inc.	b23aa80e-2af2-4a66-92ed-b1c8863be704	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	ProPharma Distribution	4304f145-24cb-dbe0-e063-6394a90a5dad	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	ProPharma Distribution	42da65ee-2402-7b51-e063-6394a90a46b7	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	41b1eb17-c0a4-cf60-e063-6394a90a67e6	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Mylan Institutional LLC	f58803b0-f173-4997-b2f8-0f415b94dacf	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Civica, Inc.	8ea475c7-d35e-47f4-8955-0df5ccd35b79	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	9a622308-7bda-4ca0-9de5-d6b3b4be3384	2025-07-16	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Lifestar Pharma LLC	1141181f-3f62-4094-bfa2-454f89a14765	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	Solco Healthcare US, LLC	b7fba679-9c2d-4dac-af53-8c1331c966c3	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	STERISCIENCE SPECIALTIES PRIVATE LIMITED	b894c436-ea67-407e-a801-f334a0c0c2d9	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Gland Pharma Limited	a223a740-dbe8-4d06-8b8b-d9104b694e62	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	Caplin Steriles Limited	f1794318-b058-4254-97b7-d4e07126efbb	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	15ea777f-2ba9-7f60-e063-6294a90a539b	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE