Orange Book drug · Generic (ANDA)

Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

Gentamicin Sulfate

ANDA 062373 10 strengths Baxter Hlthcare

Approved

Sep 07, 1982

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container?

Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container contains Gentamicin Sulfate and appears in 4 FDA Orange Book applications. ANDA 062373 is the lead filing, with 10 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: 4; lead ANDA 062373
Lead application holder: Baxter Healthcare Corp
Product presentations: 10
Marketing categories: Discontinued and Prescription
Reference roles: RS
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
001	EQ 0.8MG BASE/ML	INJECTABLEINJECTION	Discontinued	None posted	None posted
002	EQ 80MG BASE/100ML	INJECTABLEINJECTION	Prescription	None posted	None posted
003	EQ 40MG BASE/100ML	INJECTABLEINJECTION	Discontinued	None posted	None posted
004	EQ 60MG BASE/100ML	INJECTABLEINJECTION	Discontinued	None posted	None posted
005	EQ 100MG BASE/100ML	INJECTABLEINJECTION	Prescription	None posted	None posted
006	EQ 120MG BASE/100ML	INJECTABLEINJECTION	Prescription	None posted	RS
007	EQ 1.2MG BASE/ML	INJECTABLEINJECTION	Prescription	None posted	None posted
008	EQ 1.6MG BASE/ML	INJECTABLEINJECTION	Prescription	None posted	None posted
009	EQ 2MG BASE/ML	INJECTABLEINJECTION	Prescription	None posted	RS
010	EQ 2.4MG BASE/ML	INJECTABLEINJECTION	Discontinued	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

Baxter Healthcare Corp

The Orange Book identifies this organization as the applicant responsible for ANDA 062373.

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

Status varies by presentation: 4 on the Discontinued Drug Product List and 6 prescription

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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

53 other ANDAs and 3 other NDAs found

12 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

ANDA 062373 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

Gentamicin Sulfate

26 applications

Product rows: 87
Active applications: 5
Active with AB row: 0

Gentamicin Sulfate · ANDA 215236 Gentamicin Sulfate · ANDA 215237 Gentamicin Sulfate · ANDA 063149 Gentamicin Sulfate · ANDA 063106 Gentamicin Sulfate · ANDA 062612 Gentamicin Sulfate · ANDA 062366

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-062373

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

10 approved presentations · ANDA 062373

Discontinued

Strength: EQ 0.8MG BASE/ML
Dosage form: INJECTABLE
Route: INJECTION
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 07, 1982
44 yr 6 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 0.8MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 062373

Product number

001

Marketing status

Discontinued

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 Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container

3 additional filings · 3 generic

The FDA has approved 4 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 Gentamicin Sulfate In Sodium Chloride 0.9% In Plastic Container, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 062414	Hospira	Aug 15, 1983	10	—	Discontinued
ANDA 062588	Hospira	Jan 06, 1986	10	—	Discontinued
ANDA 062814	B Braun	Aug 28, 1987	14	—	Discontinued

Active-ingredient family

Brand + generics

Generic (ANDA) of Gentamicin Sulfate

View full Gentamicin Sulfate 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.