Application 206791

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No
002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 10MG BASE/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
A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2019-02-20
A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2019-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206791-001	AP
A206791-002	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	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206791-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206791-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-02-20	`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	A206791-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206791-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206791-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206791-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206791-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206791-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206791-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206791-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206791-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206791-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206791-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206791-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206791-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206791-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206791-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206791-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206791-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206791-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206791-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206791-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206791-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206791-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206791-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206791-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206791-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206791-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206791-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206791-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206791-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206791-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206791-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206791-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206791-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206791-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206791-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206791-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206791-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206791-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206791-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206791-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Somerset Therapeutics, LLC	ed91f65b-e002-43bd-bfa0-5ce8b89119e6	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206791 application number: ANDA206791 ndc (product): 70069-141 ndc (product): 70069-151

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70069-141	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-141	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-141	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-141	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-151	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-151	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-151	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current
70069-151	Cisatracurium Besylate	Cisatracurium Besylate	Somerset Therapeutics, LLC	ANDA	Current