Assyro AI

Orange Book product · Generic (ANDA)

SODIUM BICARBONATE

SODIUM BICARBONATE

Generic (ANDA)ANDA 206688TE APRX FRESENIUS KABI USA

At a glance

Aug 25, 2025

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 25, 2025

    10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM BICARBONATE

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 206688

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SODIUM BICARBONATE

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.