Orange Book drug · Generic (ANDA)

Neomycin And Polymyxin B Sulfates And Hydrocortisone

Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate

ANDA 062874 Sandoz

Approved

May 11, 1988

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Neomycin And Polymyxin B Sulfates And Hydrocortisone?

Neomycin And Polymyxin B Sulfates And Hydrocortisone contains Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate across 8 FDA applications. ANDA 062874 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: 8; lead ANDA 062874
Lead application holder: Sandoz Inc
Product presentations: 1
Marketing categories: 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	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPSOPHTHALMIC	Prescription	None posted	RS

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

Sandoz Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 062874.

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

9 other ANDAs and 3 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

ANDA 062874 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Suspension/drops · Ophthalmic

Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate

3 applications

Product rows: 3
Active applications: 1
Active with AB row: 0

Cortisporin · NDA 050169 Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone · ANDA 062623

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-062874

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

ANDA 062874

Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Dosage form: SUSPENSION/DROPS
Route: OPHTHALMIC
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
May 11, 1988
38 yr 9 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 062874

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

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 Neomycin And Polymyxin B Sulfates And Hydrocortisone

7 additional filings · 7 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 Neomycin And Polymyxin B Sulfates And Hydrocortisone, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 064053	Bausch And Lomb Inc	Dec 29, 1995	1	AT	Prescription
ANDA 062423	Sandoz	Aug 25, 1983	1	AT	Prescription
ANDA 062488	Sandoz	Nov 06, 1985	1	AT	Prescription
ANDA 065216	Saptalis Pharms	Oct 31, 2005	1	—	Discontinued
ANDA 065219	Sciegen Pharms	May 01, 2006	1	AT	Prescription
ANDA 217735	Amneal	Sep 30, 2025	1	AT	Prescription
ANDA 217803	Amneal	Oct 29, 2025	1	AT	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate

View full Hydrocortisone; Neomycin Sulfate; Polymyxin B 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.