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 2 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	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
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	15897860-d6a9-07e5-e063-6394a90aec75	2024-04-07	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Phlow Corporation	ad34ecc7-ff1f-4ee5-a235-e453873d0313	2024-03-19	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	c76d45aa-9ee2-aa65-e053-2995a90a4702	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	81628de9-e6bf-8f69-e053-2991aa0a6023	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	074abb29-72d9-b09f-e063-6294a90af0a9	2024-01-27	Warnings, Adverse reactions	Name fallback brand name: ROCURONIUM BROMIDE generic name: ROCURONIUM BROMIDE
rocuronium bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	0943a290-49e8-600f-e063-6294a90a3370	2023-11-03	Warnings, Adverse reactions	Name fallback brand name: rocuronium bromide generic name: ROCURONIUM BROMIDE
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	f01f9986-43f9-40e8-9506-11bfe78f9242	2023-08-29	Warnings, Adverse reactions	Name fallback brand name: rocuronium bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Sagent Pharmaceuticals	01825411-be08-4402-b101-cb546291c972	2023-07-20	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	BE Pharmaceuticals Inc.	1543ea2b-54ab-4088-a72a-5d71854a2dce	2023-07-12	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	c96726ef-f1fa-4ebb-ba33-3479c3902a8e	2023-06-06	Warnings, Adverse reactions	Name fallback brand name: rocuronium bromide generic name: ROCURONIUM BROMIDE
rocuronium bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	6ba5364d-52e8-a4c0-e053-2991aa0a9e2e	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: rocuronium bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Hikma Pharmaceuticals USA Inc.	d3a172a5-01ab-47d8-92ac-a8539b1d4dc4	2023-05-20	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Meitheal Pharmaceuticals Inc.	b9abaf64-760d-43e0-8669-a9ca70feab11	2023-05-09	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	9f68e273-9b0e-99e3-e053-2995a90a02d1	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	c8e9bdfb-1121-6f5b-e053-2a95a90a4627	2023-05-02	Warnings, Adverse reactions	Name fallback brand name: Rocuronium Bromide generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	f1933332-1ae0-4dc1-be4c-694849e6c9f9	2023-04-17	Warnings, Adverse reactions	Name fallback generic name: ROCURONIUM BROMIDE
Rocuronium	ROCURONIUM BROMIDE	Fresenius Kabi USA, LLC	fb9524b2-c353-4747-8954-7ca2529eabb2	2023-01-11	Warnings, Adverse reactions	Name fallback 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