Assyro AI

Orange Book product · Generic (ANDA)

STIE-CORT

HYDROCORTISONE

Generic (ANDA)ANDA 089074RX PADAGIS US

At a glance

Nov 26, 1985

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 26, 1985

    41 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE

Strength

2.5%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

ANDA 089074

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.