Application 078651

Type: ANDA
Sponsor: FRESENIUS KABI USA

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
A078651-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2008-12-29
A078651-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2008-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078651-001	AP
A078651-002	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	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078651-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078651-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-12-29	`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	A078651-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078651-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078651-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078651-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078651-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078651-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078651-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078651-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078651-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078651-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078651-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078651-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078651-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078651-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078651-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078651-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078651-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078651-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078651-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078651-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078651-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078651-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078651-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078651-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078651-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078651-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078651-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078651-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078651-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078651-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078651-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078651-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078651-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078651-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078651-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078651-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078651-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078651-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078651-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078651-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium	ROCURONIUM BROMIDE	Phlow Corporation	ad34ecc7-ff1f-4ee5-a235-e453873d0313	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078651 application number: ANDA078651 ndc (product): 81565-204
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	f1933332-1ae0-4dc1-be4c-694849e6c9f9	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078651 application number: ANDA078651 ndc (product): 63323-426
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	fb9524b2-c353-4747-8954-7ca2529eabb2	2023-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078651 application number: ANDA078651 ndc (product): 63323-426
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	209a654d-f92d-4242-bfef-2dcc90a30d3f	2022-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078651 application number: ANDA078651 ndc (product): 65219-065

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-426	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-065	Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	ANDA	Current
65293-426	Rocuronium	ROCURONIUM BROMIDE	The Medicines Company	ANDA	Current
65293-426	Rocuronium	ROCURONIUM BROMIDE	The Medicines Company	ANDA	Current
65293-427	Rocuronium	ROCURONIUM BROMIDE	The Medicines Company	ANDA	Current
65293-427	Rocuronium	ROCURONIUM BROMIDE	The Medicines Company	ANDA	Current
81565-204	Rocuronium	ROCURONIUM BROMIDE	Phlow Corporation	ANDA	Current