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Orange Book product · Generic (ANDA)

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE

Generic (ANDA)ANDA 210697TE AP1RX EUGIA PHARMA

At a glance

Nov 13, 2020

Approved

Generic (ANDA)

Application

AP1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 13, 2020

    5 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PHENYLEPHRINE HYDROCHLORIDE

Strength

50MG/5ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP1

Application

ANDA 210697

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PHENYLEPHRINE 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.