Application 088911

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	No	No
002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP		1985-02-07
A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP		1985-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A088911-001	AP
A088911-002	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 · 66 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
2026-09-14 22:38:34	2026-08	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	270MG/30ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A088911-002	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP	1985-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088911-001	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	1985-02-07	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A088911-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088911-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088911-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088911-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088911-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088911-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088911-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088911-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A088911-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088911-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A088911-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088911-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088911-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088911-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088911-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088911-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088911-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088911-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088911-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088911-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088911-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088911-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088911-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088911-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088911-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088911-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	e5e325d1-0d58-40c9-9645-3ae402ff9d92	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088911 application number: ANDA088911 ndc (product): 63323-924

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-924	Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-924	Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	APP Pharmaceuticals, LLC	ANDA	Current
63323-924	Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
70529-049	Corvatrol 0.9%	SODIUM CHLORIDE	IT3 Medical LLC	ANDA	Current
70529-049	Corvatrol 0.9%	SODIUM CHLORIDE	IT3 Medical LLC	ANDA	Current