Application 206096

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	INJECTABLE;INJECTION	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206096-001	ATRACURIUM BESYLATE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION			2017-06-22

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION	AP	2017-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION	AP	2017-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206096-001	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION		2017-06-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A206096-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206096-001	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atracurium Besylate	ATRACURIUM BESYLATE	Meitheal Pharmaceuticals Inc.	efe90ee2-fe9e-421f-9e54-2961085d3b12	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: Atracurium Besylate generic name: ATRACURIUM BESYLATE
Atracurium Besylate	ATRACURIUM BESYLATE	Hospira, Inc.	de1c2dcd-295b-47ce-b7a1-a8be59939a54	2023-11-23	Warnings, Adverse reactions	Name fallback brand name: Atracurium Besylate generic name: ATRACURIUM BESYLATE
Atracurium Besylate	ATRACURIUM BESYLATE	AuroMedics Pharma LLC	71d4bc78-57df-474b-8b19-811a959f1fce	2022-05-30	Warnings, Adverse reactions	Name fallback brand name: Atracurium Besylate generic name: ATRACURIUM BESYLATE
Atracurium Besylate	ATRACURIUM BESYLATE	AuroMedics Pharma LLC	f7b6a720-05a7-4d6a-9200-21bdc90fc1c4	2022-02-14	Warnings, Adverse reactions	Name fallback brand name: Atracurium Besylate generic name: ATRACURIUM BESYLATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-698	Atracurium Besylate	atracurium besylate	Mylan Institutional LLC	ANDA	Current