Assyro AI

Orange Book product · Generic (ANDA)

TIGECYCLINE

TIGECYCLINE

Generic (ANDA)ANDA 205722DISCN XELLIA PHARMS APS

At a glance

Oct 18, 2019

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 18, 2019

    6 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIGECYCLINE

Strength

50MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 205722

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TIGECYCLINE

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.