Application 214246

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214246-001	SUCCINYLCHOLINE CHLORIDE	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2020-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214246-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214246-001	SUCCINYLCHOLINE CHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2020-06-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214246-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214246-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214246-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214246-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214246-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214246-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214246-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214246-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214246-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214246-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214246-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214246-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214246-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214246-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214246-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214246-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214246-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214246-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214246-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214246-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214246-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214246-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214246-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214246-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214246-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214246-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214246-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214246-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214246-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214246-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214246-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214246-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214246-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214246-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214246-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214246-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214246-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214246-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Piramal Critical Care Inc	b94ff0a2-a770-47a6-e053-2995a90a7fbc	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214246 application number: ANDA214246 ndc (product): 66794-232
Succinylcholine Chloride	SUCCINYLCHOLINE CHLORIDE	Gland Pharma Limited	0fa91665-16c4-40aa-98e6-6a624b102b8f	2022-11-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214246 application number: ANDA214246 ndc (product): 68083-450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66794-232	Succinylcholine Chloride	Succinylcholine Chloride	Piramal Critical Care Inc	ANDA	Current
66794-232	Succinylcholine Chloride	Succinylcholine Chloride	Piramal Critical Care Inc	ANDA	Current
66794-232	Succinylcholine Chloride	Succinylcholine Chloride	Piramal Critical Care Inc	ANDA	Current
66794-232	Succinylcholine Chloride	Succinylcholine Chloride	Piramal Critical Care Inc	ANDA	Current
68083-450	Succinylcholine Chloride	Succinylcholine Chloride	Gland Pharma Limited	ANDA	Current
68083-450	Succinylcholine Chloride	Succinylcholine Chloride	Gland Pharma Limited	ANDA	Current
68083-450	Succinylcholine Chloride	Succinylcholine Chloride	Gland Pharma Limited	ANDA	Current
68083-450	Succinylcholine Chloride	Succinylcholine Chloride	Gland Pharma Limited	ANDA	Current