Application 207956

Type: ANDA
Sponsor: LABORATORIOS GRIFOLS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	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
A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	INJECTABLE / INJECTION	AP		2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207956-001	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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207956-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	2017-05-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207956-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207956-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207956-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207956-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207956-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207956-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207956-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207956-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207956-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207956-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207956-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207956-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207956-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207956-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207956-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207956-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207956-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207956-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207956-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207956-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207956-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207956-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207956-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207956-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207956-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207956-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207956-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207956-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207956-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207956-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207956-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207956-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207956-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207956-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207956-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207956-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207956-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207956-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207956-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207956-001	AP	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	LABORATORIOS GRIFOLS SA	eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207956 application number: ANDA207956 ndc (product): 76297-001
Sodium Chloride	SODIUM CHLORIDE	SOLA Pharmaceuticals, LLC	4d0bfd28-460a-48ba-bd17-cf75e56d62f4	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207956 application number: ANDA207956
Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	28f79c75-82d2-4912-81fc-a723b5ccf4c1	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207956 application number: ANDA207956 ndc (product): 79672-613
Sodium Chloride	SODIUM CHLORIDE	CODAN US CORPORATION	aa06e286-75c6-4d7a-959f-6008d38aa6e5	2024-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207956 application number: ANDA207956 ndc (product): 81826-001
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	e5247ed5-6170-c13f-e053-2a95a90a4101	2024-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207956 application number: ANDA207956 ndc (product): 51662-1609

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1609	0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
76297-001	Sodium Chloride	Sodium Chloride	LABORATORIOS GRIFOLS SA	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
79672-613	Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	ANDA	Current
81826-001	Sodium Chloride	SODIUM CHLORIDE	CODAN US CORPORATION	ANDA	Current