Application 078717

Type: ANDA
Sponsor: TEVA PHARMS

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 43.

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
A078717-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION			2008-11-26
A078717-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION			2008-11-26

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 · 86 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
2026-09-14 22:38:34	2026-08	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078717-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078717-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078717-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078717-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078717-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078717-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078717-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078717-002	AP	1	`ea99ee380514…`

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 brand name: rocuronium bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Sandoz Inc	cb28d869-6510-4402-9462-f6bb25fa0fa8	2022-10-13	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide 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 brand name: ROCURONIUM BROMIDE 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 brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Baxter Healthcare Corporation	31e15c3f-aefa-4379-b684-7707744fe40d	2019-09-30	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-2394	Rocuronium Bromide	Rocuronium Bromide	Teva Parenteral Medicines	ANDA	Current
0703-2395	Rocuronium Bromide	Rocuronium Bromide	Teva Parenteral Medicines	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39564	ORIG	2009-01-16
31383	ORIG	2008-12-02