Assyro AI

Orange Book product · Generic (ANDA)

TROMETHAMINE

TROMETHAMINE

Generic (ANDA)ANDA 211558TE APRX B BRAUN MEDICAL

At a glance

Dec 09, 2024

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 09, 2024

    1 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TROMETHAMINE

Strength

18GM/500ML (3.6GM/100ML)

Dosage form

SOLUTION

Route

INJECTION

TE code

AP

Application

ANDA 211558

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TROMETHAMINE

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.