Application 088400

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	LIQUID;N/A	100%	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
A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP		1984-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088400-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088400-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088400-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088400-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088400-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088400-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088400-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088400-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088400-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088400-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088400-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088400-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088400-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088400-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088400-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088400-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088400-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088400-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088400-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088400-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088400-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088400-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088400-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088400-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088400-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088400-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088400-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088400-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088400-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088400-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088400-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088400-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088400-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088400-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088400-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088400-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088400-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088400-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088400-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088400-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088400-001	AP	1	`e64feba35796…`

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
Sterile Water	WATER	Cardinal Health 107, LLC	48d75a7c-8329-48a8-bea0-a8c144ddf637	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400 ndc (product): 65219-187
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400 ndc (product): 63323-185

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
63323-185	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current
65219-187	Sterile Water	WATER	Fresenius Kabi USA, LLC	ANDA	Current