Assyro AI

Orange Book product · Generic (ANDA)

PENECORT

HYDROCORTISONE

Generic (ANDA)ANDA 088215DISCN ALLERGAN HERBERT

At a glance

Jun 06, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 06, 1984

    42 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE

Strength

1%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

ANDA 088215

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

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.