Application 205656

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A205656-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04
A205656-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205656-001	AP
A205656-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2018-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205656-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205656-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2018-04-04	`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	A205656-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205656-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205656-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205656-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205656-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205656-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205656-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205656-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205656-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205656-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205656-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205656-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205656-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205656-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205656-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205656-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205656-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205656-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205656-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205656-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205656-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205656-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205656-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205656-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205656-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205656-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205656-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205656-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205656-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rocuronium Bromide	ROCURONIUM BROMIDE	ProPharma Distribution	579c4dfd-4877-33bb-e063-6394a90ae3d9	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
Rocuronium Bromide	ROCURONIUM BROMIDE	Gland Pharma Limited	a223a740-dbe8-4d06-8b8b-d9104b694e62	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656 ndc (product): 68083-364 ndc (product): 68083-365
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	15897860-d6a9-07e5-e063-6394a90aec75	2024-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	HF Acquisition Co LLC, DBA HealthFirst	074abb29-72d9-b09f-e063-6294a90af0a9	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	f01f9986-43f9-40e8-9506-11bfe78f9242	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
Rocuronium Bromide	ROCURONIUM BROMIDE	Sagent Pharmaceuticals	01825411-be08-4402-b101-cb546291c972	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656
rocuronium bromide	ROCURONIUM BROMIDE	Hospira, Inc.	c96726ef-f1fa-4ebb-ba33-3479c3902a8e	2023-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205656 application number: ANDA205656

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-616	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
47781-616	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
47781-616	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
47781-617	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
47781-617	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
47781-617	Rocuronium Bromide	rocuronium bromide	Alvogen Inc.	ANDA	Current
68083-364	Rocuronium Bromide	Rocuronium Bromide	Gland Pharma Limited	ANDA	Current
68083-364	Rocuronium Bromide	Rocuronium Bromide	Gland Pharma Limited	ANDA	Current
68083-365	Rocuronium Bromide	Rocuronium Bromide	Gland Pharma Limited	ANDA	Current
68083-365	Rocuronium Bromide	Rocuronium Bromide	Gland Pharma Limited	ANDA	Current
70860-651	Rocuronium Bromide	rocuronium bromide	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-651	Rocuronium Bromide	rocuronium bromide	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-651	Rocuronium Bromide	rocuronium bromide	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71872-7211	Rocuronium Bromide	rocuronium bromide	Medical Purchasing Solutions, LLC	ANDA	Current
72611-756	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current
72611-756	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current
72611-756	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current
72611-757	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current
72611-757	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current
72611-757	Rocuronium Bromide	rocuronium bromide	Almaject, Inc.	ANDA	Current