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Orange Book product · Generic (ANDA)

AMLODIPINE AND OLMESARTAN MEDOXOMIL

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Generic (ANDA)ANDA 209010TE ABRX SCIEGEN PHARMS

At a glance

Dec 03, 2018

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 03, 2018

    7 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Strength

EQ 5MG BASE;20MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 209010

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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.