Application 008845

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	20MG/ML	Yes	No
002	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
004	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	No
006	QUELICIN	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	20MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N008845-001	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N008845-002	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N008845-004	QUELICIN PRESERVATIVE FREE	SUCCINYLCHOLINE CHLORIDE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N008845-006	QUELICIN	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, 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
N008845-006	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 2 of 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008845-001	QUELICIN PRESERVATIVE FREE	20MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008845-002	QUELICIN PRESERVATIVE FREE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008845-004	QUELICIN PRESERVATIVE FREE	100MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008845-006	QUELICIN	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N008845-006	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008845-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008845-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008845-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008845-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008845-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008845-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008845-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008845-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008845-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008845-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008845-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008845-006	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008845-006	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008845-006	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008845-006	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008845-006	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008845-006	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008845-006	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008845-006	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008845-006	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008845-006	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008845-006	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008845-006	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008845-006	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008845-006	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008845-006	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008845-006	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008845-006	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008845-006	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008845-006	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008845-006	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008845-006	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008845-006	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008845-006	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008845-006	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008845-006	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008845-006	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008845-006	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008845-006	AP	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUELICIN	SUCCINYLCHOLINE CHLORIDE	Hospira, Inc.	fb08161e-7711-406d-e7b3-ea4515c07983	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 008845 application number: NDA008845 ndc (product): 0409-6629

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	Quelicin	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	Quelicin	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	QUELICIN	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
0409-6629	Quelicin	Succinylcholine Chloride	Hospira, Inc.	NDA	Current
51662-1353	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1353	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
71872-7026	Quelicin	Succinylcholine Chloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7026	Quelicin	Succinylcholine Chloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7146	Quelicin	Succinylcholine Chloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7146	Quelicin	Succinylcholine Chloride	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72541	SUPPL	2022-11-02
72529	SUPPL	2022-11-02
70236	SUPPL	2022-02-23
70225	SUPPL	2022-02-22
68352	SUPPL	2021-08-12
68348	SUPPL	2021-08-12
55043	SUPPL	2018-07-30
55027	SUPPL	2018-07-27
117	SUPPL	2010-11-30
32979	SUPPL	2010-11-22