Assyro AI

Orange Book product · Generic (ANDA)

CIMETIDINE

CIMETIDINE

Generic (ANDA)ANDA 218997TE ABRX AUROBINDO PHARMA LTD

At a glance

Nov 12, 2024

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 12, 2024

    1 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CIMETIDINE

Strength

200MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 218997

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CIMETIDINE

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.