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Orange Book product · Generic (ANDA)

MIDODRINE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE

Generic (ANDA)ANDA 207613TE ABRX UNIQUE

At a glance

Nov 02, 2018

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 02, 2018

    7 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MIDODRINE HYDROCHLORIDE

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 207613

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MIDODRINE HYDROCHLORIDE

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.