Application 008453

Type: NDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANECTINE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	ANECTINE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	20MG/ML	Yes	Yes
003	ANECTINE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
004	ANECTINE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	1GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N008453-001	ANECTINE	SUCCINYLCHOLINE CHLORIDE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982
N008453-002	ANECTINE	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N008453-003	ANECTINE	SUCCINYLCHOLINE CHLORIDE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982
N008453-004	ANECTINE	SUCCINYLCHOLINE CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N008453-002	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008453-001	ANECTINE	500MG/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008453-002	ANECTINE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008453-003	ANECTINE	50MG/ML	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008453-004	ANECTINE	1GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N008453-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N008453-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N008453-002	AP	1	`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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anectine	SUCCINYLCHOLINE CHLORIDE	Sandoz Inc	a1e5d29f-111e-4a44-addf-beeb6ea81711	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 008453 application number: NDA008453 ndc (product): 0781-3411
Anectine	SUCCINYLCHOLINE CHLORIDE	Civica, Inc.	0b990f84-9515-44bd-a97d-a97bbead065c	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 008453 application number: NDA008453 ndc (product): 72572-750
Anectine	SUCCINYLCHOLINE CHLORIDE	Sandoz Inc	04a4e6f5-6fa1-42e1-a3f9-21fca7786b15	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 008453 application number: NDA008453 ndc (product): 0781-9053

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3009	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-3411	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
0781-9053	Anectine	Succinylcholine Chloride	Sandoz Inc	NDA	Current
72572-750	Anectine	Succinylcholine Chloride	Civica, Inc.	NDA	Current
72572-750	Anectine	Succinylcholine Chloride	Civica, Inc.	NDA	Current
72572-750	Anectine	Succinylcholine Chloride	Civica, Inc.	NDA	Current
72572-750	Anectine	Succinylcholine Chloride	Civica, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72540	SUPPL	2022-11-02
72528	SUPPL	2022-11-02
65693	SUPPL	2020-12-22
55042	SUPPL	2018-07-30
55028	SUPPL	2018-07-27
101	SUPPL	2010-11-30
10703	SUPPL	2010-11-22
20013	SUPPL	2000-06-12
20012	SUPPL	2000-06-12
20011	SUPPL	2000-06-12
20010	SUPPL	2000-06-12