Assyro AI

Orange Book product · Generic (ANDA)

FLUDROCORTISONE ACETATE

FLUDROCORTISONE ACETATE

Generic (ANDA)ANDA 040431TE ABRX IMPAX LABS

At a glance

Mar 18, 2002

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 18, 2002

    24 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FLUDROCORTISONE ACETATE

Strength

0.1MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 040431

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of FLUDROCORTISONE ACETATE

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.