Application 218343

Type: NDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 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
N218343-001	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	2024-07-26

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218343-001	11925661	2041-10-12	U-4185	Drug product	2026-07-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218343-001	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-07-26	`a50c72e98297…`

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
2026-08-18 06:07:40	2026-07	N218343-001	11925661	2041-10-12	U-4185	Drug product	2026-07-27	`caaa826d4ba7…`

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
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATES IN SODIUM CHLORIDE	Amneal Pharmaceuticals LLC	dce22c93-aa48-48a9-ac8b-716400d33c9e	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218343 application number: NDA218343

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82321	ORIG	2025-05-27
79246	ORIG	2024-07-29
79237	ORIG	2024-07-29