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 43.

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
2026-09-14 22:38:34	2026-08	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD	2021-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215143-001	SUCCINYLCHOLINE CHLORIDE	100MG/5ML (20MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS		RLD	2021-08-20	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215143-001	12295932	2041-11-02	Drug product	2025-06-10	`caaa826d4ba7…`
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 2 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	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
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Zydus Lifesciences Limited	c7f409ed-e4f4-4cd6-8f37-93f505dd986d	2023-10-19		Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	Eugia US LLC	1b3f3c63-0500-4c0a-8ac2-3d525ccf4537	2023-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	8efd638d-0fc5-1678-e053-2a95a90aafd2	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	896a4238-667d-45b0-e053-2a95a90a60dd	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	b621b0ed-abf7-75f1-e053-2995a90a31ca	2023-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	d89d3442-5e73-363e-e053-2a95a90a506e	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	d89d8d7b-ecb2-72a0-e053-2995a90af208	2023-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Medical Purchasing Solutions, LLC	d89f49d5-e41c-ba14-e053-2995a90a0268	2023-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Lifestar Pharma LLC	3e12657f-0e9b-4323-9f64-5420713da156	2023-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Meitheal Pharmaceuticals Inc.	3196be9d-0759-4a20-86a5-7a7b98b97127	2023-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Zydus Pharmaceuticals USA Inc.	017e5ad4-028e-4e34-ac09-d0c8d64c880a	2022-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Gland Pharma Limited	0fa91665-16c4-40aa-98e6-6a624b102b8f	2022-11-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Micro Labs Limited	204f1c24-4bf6-40d5-95f3-a732db28e033	2022-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Amring Pharmaceuticals Inc.	23bb29da-55a6-4f06-b3a4-2f7b65ec5909	2022-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE
SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	b972f6e4-4f9f-4c68-e053-2995a90ae11b	2021-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SUCCINYLCHOLINE CHLORIDE generic name: SUCCINYLCHOLINE CHLORIDE
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Indoco Remedies Limited	53e064bb-f71c-485f-b466-58a0739e7753	2020-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Succinylcholine Chloride generic name: SUCCINYLCHOLINE CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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