Orange Book drug · Brand (NDA)

Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container

Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate

RLDNDA 020171 Fresenius Medcl

Approved

Aug 19, 1992

Strengths

Listed patents

What does the FDA Orange Book show for Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container?

Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container (Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate) is NDA 020171, a new drug Orange Book application with 1 presentation. FDA rows establish regulatory data, not inventory or clinical labeling. Exact application label matching remains pending.

FDA application: NDA 020171
Application holder: Fresenius Medical Care North America
Product presentations: 1
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: AT
Listed patents: 0
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
003	18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML	SOLUTIONINTRAPERITONEAL	Prescription	AT	RLDRS

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

Fresenius Medical Care North America

The Orange Book identifies this organization as the applicant responsible for NDA 020171.

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 prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AT across rated presentations

An AT code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

1 other ANDA and 6 other NDAs 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 020171 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 · Intraperitoneal

Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate

8 applications

Product rows: 49
Active applications: 5
Active with AB row: 0

Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container · NDA 020183 Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container · NDA 020163 Dialyte Lm/ Dextrose 1.5% In Plastic Container · NDA 018460 Delflex W/ Dextrose 1.5% In Plastic Container · NDA 018883 Delflex W/ Dextrose 1.5% In Plastic Container · NDA 018379 Dianeal 137 W/ Dextrose 1.5% In Plastic Container · NDA 017512

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-020171

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 020171

TE ATRLDRS

Strength: 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Dosage form: SOLUTION
Route: INTRAPERITONEAL
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Aug 19, 1992
34 yr 5 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Strength

18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML

Dosage form

SOLUTION

Route

INTRAPERITONEAL

TE code

Application

NDA 020171

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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.

View full Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate 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.