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 44.

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 2 of 3 · 88 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
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…`
2022-03-09 01:35 UTC	2022-03	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2008-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078717-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078717-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION		2008-11-26	`3a93d1ddd44b…`

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 1 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	HF Acquisition Co. LLC, DBA HealthFirst	58ce3f40-cbb9-db9e-e063-6394a90ae611	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co. LLC, DBA HealthFirst	58b92bce-5ff8-6741-e063-6294a90a25e9	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	04c9812d-5aa3-4949-ad02-c618028f1bb0	2026-08-02	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
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

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