Assyro AI

Orange Book product · Generic (ANDA)

HYDROCORTISONE BUTYRATE

HYDROCORTISONE BUTYRATE

Generic (ANDA)ANDA 202145DISCN GLENMARK PHARMS LTD

At a glance

Sep 27, 2013

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 27, 2013

    12 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE BUTYRATE

Strength

0.1%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

ANDA 202145

Product number

001

Marketing status

DISCN

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.