Orange Book drug · Brand (NDA)

Physiosol In Plastic Container

Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate

NDA 017637 Otsuka Icu Medcl

Approved

Jul 08, 1982

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Physiosol In Plastic Container?

Physiosol In Plastic Container contains Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate across 2 FDA applications. NDA 017637 is the lead filing; other filings are listed separately. This page preserves Orange Book facts and source limits. Clinical labeling requires an exact application-matched source.

FDA applications: 2; lead NDA 017637
Lead application holder: Otsuka Icu Medical LLC
Product presentations: 1
Marketing categories: Prescription
Reference roles: None posted
TE codes: None posted
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
002	30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML	SOLUTIONIRRIGATION	Prescription	None posted	None posted

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

Otsuka Icu Medical LLC

The Orange Book identifies this organization as the applicant responsible for NDA 017637.

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

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

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

2 other ANDAs and 6 other NDAs found

1 of the related ANDA application is 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 017637 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 · Irrigation

Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate

4 applications

Product rows: 5
Active applications: 2
Active with AB row: 0

Synovalyte In Plastic Container · NDA 019326 Physiolyte In Plastic Container · NDA 019024

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-017637

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 017637

Strength: 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML
Dosage form: SOLUTION
Route: IRRIGATION
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Jul 08, 1982
44 yr 8 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

Strength

30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Dosage form

SOLUTION

Route

IRRIGATION

TE code

Not listed

Application

NDA 017637

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

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.

Other FDA applications for Physiosol In Plastic Container

1 additional filing

The FDA has approved 2 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 Physiosol In Plastic Container, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 018406	Hospira Inc	Approved Prior to Jan 1, 1982	1	—	Discontinued

Active-ingredient family

Brand + generics

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate 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.