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Orange Book product · Generic (ANDA)

HYDROXYPROGESTERONE CAPROATE

HYDROXYPROGESTERONE CAPROATE

Generic (ANDA)ANDA 211142DISCN EUGIA PHARMA

At a glance

May 09, 2019

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 09, 2019

    7 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROXYPROGESTERONE CAPROATE

Strength

1250MG/5ML (250MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR

TE code

Not listed

Application

ANDA 211142

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROXYPROGESTERONE CAPROATE

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.