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 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
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.

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
2026-08-01 22:54:32	2026-06	A201836-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2020-11-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201836-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2020-11-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201836-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201836-002	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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