Application 201836

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No
002	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	INJECTABLE;INJECTION	EQ 10MG BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201836-001	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2020-11-06
A201836-002	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2020-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201836-001	AP
A201836-002	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 2 · 74 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	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2020-11-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201836-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201836-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201836-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201836-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201836-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201836-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201836-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201836-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201836-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201836-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201836-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201836-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201836-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201836-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201836-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201836-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201836-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201836-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201836-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201836-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201836-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201836-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201836-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201836-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201836-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201836-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201836-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201836-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201836-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201836-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201836-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201836-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201836-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201836-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201836-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201836-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201836-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201836-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201836-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201836-002	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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Avenacy, LLC	1c6a8b98-deac-4e25-b4a0-5d0af5090281	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Hospira, Inc.	67908e20-044d-454d-9c51-bf106e817bd0	2026-05-25	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Camber Pharmaceuticals Inc.	d8b5eb77-b393-4cd7-86c5-d2a9d131f96d	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Somerset Therapeutics, LLC	23daa1f8-2a07-449d-97a6-11efdb0b9836	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Somerset Therapeutics, LLC	ed91f65b-e002-43bd-bfa0-5ce8b89119e6	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Eugia US LLC	2cb05c7e-6228-4e2d-a270-7659e3db3fa7	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Hikma Pharmaceuticals USA Inc.	c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Hikma Pharmaceuticals USA Inc.	46c815f6-7a3d-43a3-b470-3377b126ba09	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium besylate	CISATRACURIUM BESYLATE	Gland Pharma Limited	0bacc37a-5e7f-4f05-9206-56fc8041c1ad	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium	CISATRACURIUM BESYLATE	Fresenius Kabi USA, LLC	f78a07e2-0d3b-4460-b29e-8c10c90afbda	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: CISATRACURIUM BESYLATE
Cisatracurium besylate	CISATRACURIUM BESYLATE	Caplin Steriles Limited	93101770-10a1-4bad-a762-289c793d8ace	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Armas Pharmaceuticals	dd078343-1f43-4405-8048-cf6c4f456549	2025-01-15	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
cisatracurium besylate	CISATRACURIUM BESYLATE	Sandoz Inc	2ee0358e-2cce-40d3-9fcf-1b9088815c98	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE
cisatracurium besylate	CISATRACURIUM BESYLATE	Sandoz Inc	291a55dd-ab45-4660-b513-4ecb729eb051	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium besylate	CISATRACURIUM BESYLATE	Slate Run Pharmaceuticals, LLC	49185e78-d244-4426-90ef-ad109824eddb	2024-08-29	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE
cisatracurium besylate	CISATRACURIUM BESYLATE	Zydus Pharmaceuticals USA Inc.	f9e1a84b-d19e-46c5-b40f-944ac1543dac	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium besylate	CISATRACURIUM BESYLATE	Slate Run Pharmaceuticals, LLC	e06c4d57-bfc7-45ad-b1cd-b5b88dc43b50	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Meitheal Pharmaceuticals Inc.	1be30efe-4beb-411a-bf82-6e4ea68fd262	2023-06-05	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Meitheal Pharmaceuticals Inc.	7c8c41b6-d07c-4740-84b7-603289104c59	2023-01-19	Warnings, Adverse reactions	Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE
cisatracurium besylate	CISATRACURIUM BESYLATE	Zydus Lifesciences Limited	e145a40e-b046-4064-b35e-0da40ff3703e	2022-11-05		Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-668	Cisatracurium Besylate	cisatracurium besylate	Sagent Pharmaceuticals	ANDA	Current
25021-668	Cisatracurium Besylate	cisatracurium besylate	Sagent Pharmaceuticals	ANDA	Current
25021-669	Cisatracurium Besylate	cisatracurium besylate	Sagent Pharmaceuticals	ANDA	Current
25021-669	Cisatracurium Besylate	cisatracurium besylate	Sagent Pharmaceuticals	ANDA	Current