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Orange Book product · Generic (ANDA)

SODIUM BICARBONATE

SODIUM BICARBONATE

Generic (ANDA)ANDA 211091TE APRX EXELA PHARMA

At a glance

Jun 20, 2019

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 20, 2019

    7 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM BICARBONATE

Strength

5MEQ/10ML (0.5MEQ/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 211091

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.