Assyro AI

Orange Book product · Generic (ANDA)

HYDROCORTISONE

HYDROCORTISONE

Generic (ANDA)ANDA 081203TE ATRX FOUGERA PHARMS INC

At a glance

May 28, 1993

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 28, 1993

    33 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE

Strength

2.5%

Dosage form

OINTMENT

Route

TOPICAL

TE code

AT

Application

ANDA 081203

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.