Orange Book drug · Brand (NDA)

Potassium Phosphates

Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic

DiscontinuedRLDNDA 212121 Cmp Dev LLC

Approved

Sep 19, 2019

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Potassium Phosphates?

Potassium Phosphates contains Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic and appears in 8 FDA Orange Book applications. NDA 212121 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications: 8; lead NDA 212121
Lead application holder: Cmp Development LLC
Product presentations: 1
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 1
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)	SOLUTIONINTRAVENOUS	Discontinued	None posted	RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Cmp Development LLC

The Orange Book identifies this organization as the applicant responsible for NDA 212121.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

1 presentation listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

1 listed patent expiration and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 19, 2039. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 212121 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intravenous

Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic

9 applications

Product rows: 22
Active applications: 8
Active with AB row: 0

Potassium Phosphates In 0.9% Sodium Chloride · NDA 218343

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-212121

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 212121

RLDDiscontinued

Strength: 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)
Dosage form: SOLUTION
Route: INTRAVENOUS
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 19, 2019
6 yr 11 mo ago
Today
Patent 10632150 expires
Listed drug product patent expiration.
Apr 19, 2039
in 12 yr 11 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Strength

4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212121

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10632150	Apr 19, 2039	in 12 yr 11 mo	ProductU-2789

Other FDA applications for Potassium Phosphates

7 additional filings · 6 generic

The FDA has approved 8 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Potassium Phosphates, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 212832	Fresenius Kabi USA	Nov 26, 2019	3	AP	Prescription
ANDA 216274	Am Regent	Oct 02, 2023	3	AP	Prescription
ANDA 216344	Amneal	Oct 10, 2023	3	AP	Prescription
ANDA 217459	Hospira	Sep 11, 2025	1	AP	Prescription
ANDA 217726	Somerset Theraps LLC	Jul 11, 2024	2	AP	Prescription
ANDA 217892	Cipla	Jan 24, 2025	3	AP	Prescription
ANDA 220373	Caplin	Mar 12, 2026	3	AP	Prescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Potassium Phosphates In 0.9% Sodium ChlorideBrand (NDA)
NDA 218343 · Amneal
2024

View full Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.