Assyro AI

Orange Book product · Generic (ANDA)

HYDROCORTISONE

HYDROCORTISONE

Generic (ANDA)ANDA 040879TE ATRX RISING

At a glance

Aug 20, 2010

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 20, 2010

    16 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE

Strength

2.5%

Dosage form

CREAM

Route

TOPICAL

TE code

AT

Application

ANDA 040879

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

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.