Application 208122

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	450MG/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
A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE / INJECTION	AP		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208122-001	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	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208122-001	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	450MG/100ML	INJECTABLE / INJECTION	AP	2018-07-23	`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	A208122-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208122-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208122-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208122-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208122-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208122-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208122-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208122-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208122-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208122-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208122-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208122-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208122-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208122-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208122-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208122-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208122-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208122-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208122-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208122-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208122-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208122-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208122-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208122-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208122-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208122-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208122-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208122-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208122-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208122-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208122-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208122-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208122-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208122-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208122-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208122-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208122-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208122-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208122-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208122-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	83994d0c-8484-4505-abb5-8a384ed12288	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122 ndc (product): 63323-626
sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	8df7dcf6-8714-6caf-e053-2995a90ab8cc	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122 ndc (product): 17271-700
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	239a5af1-7498-480f-862c-ab7c3d89d183	2024-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208122 application number: ANDA208122 ndc (product): 65219-228 ndc (product): 65219-232 ndc (product): 65219-226 ndc (product): 65219-230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17271-700	sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
17271-700	sodium chloride	SODIUM CHLORIDE	Becton Dickinson and Company	ANDA	Current
63323-626	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-626	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-626	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-226	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-226	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-228	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-228	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-230	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-230	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-232	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-232	Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current