Assyro AI

Orange Book product · Brand (NDA)

TECHNEGAS KIT

TECHNETIUM TC-99M LABELED CARBON

Brand (NDA)NDA 022335RX CYCLOMEDICA

At a glance

Sep 29, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 29, 2023

    2 yr 9 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Sep 29, 2026

    in 3 mo

  4. Patent 7722856 expires

    Listed method-of-use patent (U-4442) expiration.

    Feb 24, 2031

    in 4 yr 9 mo

Pharmaceutical detail

Active ingredient

TECHNETIUM TC-99M LABELED CARBON

Strength

N/A

Dosage form

AEROSOL

Route

INHALATION

TE code

Not listed

Application

NDA 022335

Product number

001

Marketing status

RX

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.

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Sep 29, 2026

    in 3 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7722856Feb 24, 2031in 4 yr 9 mo
U-4442
Agent CTA Background

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