Application 091115

Type: ANDA
Sponsor: TAMARANG

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
A091115-001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP		2012-08-27
A091115-002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP		2012-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091115-001	AP
A091115-002	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	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091115-001	ROCURONIUM BROMIDE	50MG/5ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091115-002	ROCURONIUM BROMIDE	100MG/10ML (10MG/ML)	INJECTABLE / INJECTION	AP	2012-08-27	`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	A091115-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091115-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091115-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091115-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091115-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091115-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091115-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091115-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091115-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091115-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091115-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091115-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091115-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091115-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091115-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091115-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091115-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091115-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091115-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091115-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091115-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091115-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091115-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091115-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091115-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091115-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091115-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091115-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091115-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091115-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091115-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091115-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091115-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091115-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091115-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091115-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091115-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091115-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091115-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091115-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
rocuronium bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	0943a290-49e8-600f-e063-6294a90a3370	2023-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091115 application number: ANDA091115
rocuronium bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	6ba5364d-52e8-a4c0-e053-2991aa0a9e2e	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091115 application number: ANDA091115 ndc (product): 71872-7036
Rocuronium Bromide	ROCURONIUM BROMIDE	Medical Purchasing Solutions, LLC	c8e9bdfb-1121-6f5b-e053-2a95a90a4627	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091115 application number: ANDA091115 ndc (product): 71872-7262
rocuronium bromide	ROCURONIUM BROMIDE	XGen Pharmaceuticals DJB, Inc.	b73f192c-2912-4ec3-9b4f-05a58d9b35ba	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091115 application number: ANDA091115 ndc (product): 39822-4200
Rocuronium Bromide	ROCURONIUM BROMIDE	Baxter Healthcare Corporation	31e15c3f-aefa-4379-b684-7707744fe40d	2019-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091115 application number: ANDA091115 ndc (product): 43066-013 ndc (product): 43066-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
39822-4200	rocuronium bromide	rocuronium bromide	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-4200	rocuronium bromide	rocuronium bromide	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-4200	rocuronium bromide	rocuronium bromide	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-4200	rocuronium bromide	rocuronium bromide	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
43066-007	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-007	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-007	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-007	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-013	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-013	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-013	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
43066-013	Rocuronium Bromide	Rocuronium Bromide	Baxter Healthcare Corporation	ANDA	Current
55579-400	Rocuronium Bromide	ROCURONIUM BROMIDE	Solupharm Pharmazeutische Erzeugnisse GmbH	ANDA	Current
71872-7036	rocuronium bromide	rocuronium bromide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7036	rocuronium bromide	rocuronium bromide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7262	Rocuronium Bromide	Rocuronium Bromide	Medical Purchasing Solutions, LLC	ANDA	Current