Application 212832

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Yes	Yes
002	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Yes	Yes
003	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Yes	Yes
004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	Yes	Yes
005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212832-001	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26
N212832-002	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26
N212832-003	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26
N212832-004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09
N212832-005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N212832-001	AP
N212832-002	AP
N212832-003	AP

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212832-004	11813291	2041-10-12	U-4185	Drug product	2025-05-22
N212832-004	11925661	2041-10-12	U-4185	Drug product	2025-05-22
N212832-005	11813291	2041-10-12	U-4185	Drug product	2025-05-22
N212832-005	11925661	2041-10-12	U-4185	Drug product	2025-05-22

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 4 · 122 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	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML(236MG/ML); 1.12GM/5ML(224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML(236MG/ML); 3.36GM/15ML(224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML(236MG/ML); 11.2GM/50ML(224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/100ML(11.8MG/ML); 1.12GM/100ML(11.2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML(4.72MG/ML); 1.12GM/250ML(4.48MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-002	POTASSIUM PHOSPHATES	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-003	POTASSIUM PHOSPHATES	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212832-001	POTASSIUM PHOSPHATES	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-11-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	N212832-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212832-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212832-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212832-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212832-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212832-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212832-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212832-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212832-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212832-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212832-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212832-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212832-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212832-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212832-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212832-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212832-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212832-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212832-001	AP	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212832-004	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-004	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-005	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212832-005	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-004	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-004	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-005	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212832-005	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212832-004	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-004	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-005	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212832-005	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212832-004	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212832-004	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212832-005	11813291	2041-10-12	U-4185	Drug product	2025-05-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212832-005	11925661	2041-10-12	U-4185	Drug product	2025-05-22	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Phosphates	POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC	CIVICA, INC.	f7702b2f-d0d1-4696-896d-571607fc0dc8	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212832 application number: NDA212832
Potassium Phosphates	POTASSIUM PHOSPHATES	Fresenius Kabi USA, LLC	357c3020-ea6f-4401-a2e7-cebb82b03144	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212832 application number: NDA212832
Potassium Phosphates	POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC	Fresenius Kabi USA, LLC	475f5cd7-45bd-412a-b419-9962585d6cda	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212832 application number: NDA212832 ndc (product): 65219-056 ndc (product): 65219-052 ndc (product): 65219-054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-052	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-052	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-054	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-054	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-056	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-056	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79536	SUPPL	2024-09-03
79525	SUPPL	2024-09-03
62808	ORIG	2020-05-04
61086	ORIG	2019-11-27
61071	ORIG	2019-11-27