Assyro AI

Orange Book product · Brand (NDA)

FLONASE SENSIMIST ALLERGY RELIEF

FLUTICASONE FUROATE

Brand (NDA)NDA 022051OTC HALEON US HOLDINGS

At a glance

Aug 02, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 02, 2016

    10 yr ago

  2. Patent 8062264 expires

    Listed drug product patent expiration.

    Apr 05, 2026

    3 mo ago

  3. Today

  4. Patent 8347879 expires

    Listed drug product patent expiration.

    Jul 15, 2028

    in 2 yr 1 mo

  5. Patent 8147461 expires

    Listed drug product patent expiration.

    Oct 15, 2028

    in 2 yr 4 mo

Pharmaceutical detail

Active ingredient

FLUTICASONE FUROATE

Strength

0.0275MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 022051

Product number

002

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 (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8062264Apr 05, 20263 mo ago
Product
8347879Jul 15, 2028in 2 yr 1 mo
Product
8147461Oct 15, 2028in 2 yr 4 mo
Product
Agent CTA Background

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