Assyro AI

Orange Book product · Brand (NDA)

RHINOCORT ALLERGY

BUDESONIDE

Brand (NDA)NDA 020746OTC KENVUE BRANDS
View BUDESONIDE familyOpen on FDA Orange Book

At a glance

Mar 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 23, 2015

    11 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BUDESONIDE

Strength

0.032MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 020746

Product number

003

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo