Application 209997

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INJECTABLE;INJECTION	142MG/ML;276MG/ML	No	No
002	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SOLUTION;INTRAVENOUS	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	No	No
003	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SOLUTION;INTRAVENOUS	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209997-001	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30
A209997-002	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30
A209997-003	SODIUM PHOSPHATES	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209997-001	AP
A209997-002	AP
A209997-003	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 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209997-001	SODIUM PHOSPHATES	1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209997-002	SODIUM PHOSPHATES	4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209997-003	SODIUM PHOSPHATES	13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	2022-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP		2022-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP		2022-03-30	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209997-001	SODIUM PHOSPHATES	142MG/ML;276MG/ML	INJECTABLE / INJECTION	AP	RS	2022-03-30	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	A209997-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209997-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209997-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209997-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209997-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209997-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209997-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209997-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209997-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209997-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209997-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209997-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209997-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209997-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209997-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209997-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209997-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209997-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209997-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209997-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209997-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209997-001	AP	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209997-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209997-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209997-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209997-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209997-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209997-001	AP	1	`a67488948f0b…`

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
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Fresenius Kabi USA, LLC	5bf47be3-f3fe-452b-8113-941796498345	2022-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209997 application number: ANDA209997 ndc (product): 63323-884 ndc (product): 63323-881 ndc (product): 63323-886

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-881	Sodium Phosphates	sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous	Fresenius Kabi USA, LLC	ANDA	Current
63323-884	Sodium Phosphates	sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous	Fresenius Kabi USA, LLC	ANDA	Current
63323-886	Sodium Phosphates	sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71755	ORIG	2022-08-09