Assyro AI

Orange Book product · Generic (ANDA)

HYDROCORTISONE

HYDROCORTISONE

Generic (ANDA)ANDA 040351DISCN FOUGERA PHARMS

At a glance

Jul 25, 2000

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 25, 2000

    26 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE

Strength

2.5%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

ANDA 040351

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.