Orange Book drug · Brand (NDA)

Dobutamine Hydrochloride In Dextrose 5% In Plastic Container

Dobutamine Hydrochloride

RLDNDA 020201 4 strengths Hospira

Approved

Oct 19, 1993

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container?

Dobutamine Hydrochloride In Dextrose 5% In Plastic Container contains Dobutamine Hydrochloride and appears in 2 FDA Orange Book applications. NDA 020201 is the lead filing, with 4 presentations 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: 2; lead NDA 020201
Lead application holder: Hospira Inc
Product presentations: 4
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: AP
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
001	EQ 200MG BASE/100ML	INJECTABLEINJECTION	Prescription	AP	RLDRS
002	EQ 100MG BASE/100ML	INJECTABLEINJECTION	Prescription	AP	RLDRS
003	EQ 50MG BASE/100ML	INJECTABLEINJECTION	Prescription	AP	RLDRS
006	EQ 400MG BASE/100ML	INJECTABLEINJECTION	Prescription	AP	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

Hospira Inc

The Orange Book identifies this organization as the applicant responsible for NDA 020201.

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

4 presentations 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 AP across rated presentations

An AP 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

12 other ANDAs and 2 other NDAs found

3 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 020201 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Injectable · Injection

Dobutamine Hydrochloride

16 applications

Product rows: 24
Active applications: 5
Active with AB row: 0

Dobutamine Hydrochloride In Dextrose 5% · NDA 020269 Dobutrex · NDA 017820 Dobutamine Hydrochloride · ANDA 216131 Dobutamine Hydrochloride · ANDA 074545 Dobutamine Hydrochloride · ANDA 074995 Dobutamine Hydrochloride · ANDA 074279

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-020201

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.

Strengths & dosage forms

4 approved presentations · NDA 020201

TE APRLDRS

Strength: EQ 200MG BASE/100ML
Dosage form: INJECTABLE
Route: INJECTION
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Oct 19, 1993
33 yr 3 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

DOBUTAMINE HYDROCHLORIDE

Strength

EQ 200MG BASE/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Application

NDA 020201

Product number

001

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.

Other FDA applications for Dobutamine Hydrochloride In Dextrose 5% 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 Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 020255	Baxter Hlthcare	Oct 19, 1993	4	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.

View full Dobutamine Hydrochloride 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.