Assyro AI

Orange Book product · Generic (ANDA)

BETAINE

BETAINE

Generic (ANDA)ANDA 214864TE ABRX NOVITIUM PHARMA

At a glance

Nov 23, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 23, 2021

    4 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BETAINE

Strength

1GM/SCOOPFUL

Dosage form

FOR SOLUTION

Route

ORAL

TE code

AB

Application

ANDA 214864

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BETAINE

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.