Assyro AI

Orange Book product · Generic (ANDA)

HYDROCORTISONE BUTYRATE

HYDROCORTISONE BUTYRATE

Generic (ANDA)ANDA 209556TE ABRX THE J MOLNER

At a glance

Nov 21, 2017

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 21, 2017

    8 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE BUTYRATE

Strength

0.1%

Dosage form

LOTION

Route

TOPICAL

TE code

AB

Application

ANDA 209556

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HYDROCORTISONE BUTYRATE

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.