Application 215143

Type: NDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	100MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N215143-001	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD	2021-08-20

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215143-001	12295932	2041-11-02		Drug product	2025-06-10

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
2026-02-19 14:30 UTC	2026-02	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	AP	RLD, RS	2021-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2021-08-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD	2021-08-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215143-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215143-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215143-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215143-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215143-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215143-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215143-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215143-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215143-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215143-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215143-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215143-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215143-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215143-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215143-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215143-001	AP	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`a50c72e98297…`

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Somerset Therapeutics, LLC	690a0231-dbba-4695-a843-842a14c6587c	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Somerset Therapeutics, LLC	499a4ba0-d466-4342-88da-9f1eb6098692	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
QUELICIN	SUCCINYLCHOLINE CHLORIDE	Hospira, Inc.	fb08161e-7711-406d-e7b3-ea4515c07983	2026-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Nordic Pharma, Inc.	1e5891e2-e1e4-4587-b32c-b2e8082df9b6	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	STERISCIENCE SPECIALTIES PRIVATE LIMITED	1d4302db-a0d5-d0e8-e063-6294a90a22f8	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	Henry Schein, Inc.	7d0f0431-e616-49c2-80d8-0752a45428db	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Piramal Critical Care Inc	b94ff0a2-a770-47a6-e053-2995a90a7fbc	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Meitheal Pharmaceuticals Inc.	e21bff70-5247-4763-b984-b939eb0a1fc1	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	REMEDYREPACK INC.	efe5a242-5ba0-4b14-844c-206a79850d81	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	ProPharma Distribution	386a63e7-d062-a4c7-e063-6394a90ae77c	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Fresenius Kabi USA LLC	f4d496fb-588f-459d-b218-0fc0ffa2715f	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Fresenius Kabi USA LLC	ce12d907-eae4-4fba-b85e-170fac1819c6	2025-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Devatis, Inc.	e235eb7d-5ce2-4884-9d16-493c90d7beba	2024-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Camber Pharmaceuticals, Inc.	3deac02b-392c-4ee4-9abf-7fe5b8975147	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	Baxter Healthcare Corporation	30f58922-3c74-4813-ace0-fcd2024acd09	2024-06-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	Fresenius Kabi USA, LLC	4e2d3394-c9e0-4191-ba0d-da21034c22b5	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	BE Pharmaceuticals Inc.	6e6e0ce7-c73c-407f-9678-724425f24976	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Anectine	SUCCINYLCHOLINE CHLORIDE	Sandoz Inc	a1e5d29f-111e-4a44-addf-beeb6ea81711	2023-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SUCCINYLCHOLINE CHLORIDE
Anectine	SUCCINYLCHOLINE CHLORIDE	Civica, Inc.	0b990f84-9515-44bd-a97d-a97bbead065c	2023-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Hikma Pharmaceuticals USA Inc.	488e1689-84d4-4f96-ac85-fa0cbc661cb6	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE

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
0641-6234	Succinylcholine Chloride	Succinylcholine Chloride	Hikma Pharmaceuticals USA Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72542	SUPPL	2022-11-02
72536	SUPPL	2022-11-02
70702	SUPPL	2022-04-05
70556	SUPPL	2022-03-18
70051	ORIG	2022-02-02
68450	ORIG	2021-08-24
68437	ORIG	2021-08-22