Application 204679

Type: ANDA
Sponsor: WEST WARD PHARM CORP

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
002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	100MG/10ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204679-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2017-02-28
A204679-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2017-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204679-001	AP
A204679-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204679-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204679-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2017-02-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204679-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204679-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204679-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204679-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204679-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204679-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204679-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204679-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204679-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204679-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204679-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204679-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204679-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204679-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204679-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204679-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204679-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204679-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204679-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204679-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204679-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204679-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204679-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204679-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204679-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204679-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204679-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204679-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204679-002	AP	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	Civica, Inc.	8ea475c7-d35e-47f4-8955-0df5ccd35b79	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679 ndc (product): 72572-650 ndc (product): 72572-651
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	15ea777f-2ba9-7f60-e063-6294a90a539b	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679
Rocuronium Bromide	ROCURONIUM BROMIDE	Hikma Pharmaceuticals USA Inc.	d3a172a5-01ab-47d8-92ac-a8539b1d4dc4	2023-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204679 application number: ANDA204679 ndc (product): 0143-9250 ndc (product): 0143-9251

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
0143-9250	Rocuronium Bromide	Rocuronium Bromide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9250	Rocuronium Bromide	Rocuronium Bromide	West-Ward Pharmaceuticals	ANDA	Current
0143-9250	Rocuronium Bromide	Rocuronium Bromide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9251	Rocuronium Bromide	Rocuronium Bromide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9251	Rocuronium Bromide	Rocuronium Bromide	West-Ward Pharmaceuticals	ANDA	Current
0143-9251	Rocuronium Bromide	Rocuronium Bromide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
72572-650	Rocuronium Bromide	Rocuronium Bromide	Civica, Inc.	ANDA	Current
72572-650	Rocuronium Bromide	Rocuronium Bromide	Civica, Inc.	ANDA	Current
72572-651	Rocuronium Bromide	Rocuronium Bromide	Civica, Inc.	ANDA	Current
72572-651	Rocuronium Bromide	Rocuronium Bromide	Civica, Inc.	ANDA	Current