Assyro AI

Orange Book product · Generic (ANDA)

METARAMINOL BITARTRATE

METARAMINOL BITARTRATE

Generic (ANDA)ANDA 211304RX AZURITY

At a glance

Aug 24, 2021

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 24, 2021

    4 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METARAMINOL BITARTRATE

Strength

EQ 10MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 211304

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METARAMINOL BITARTRATE

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.