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Orange Book product · Generic (ANDA)

HYDROCORTISONE SODIUM SUCCINATE

HYDROCORTISONE SODIUM SUCCINATE

Generic (ANDA)ANDA 219856TE APRX APOTEX

At a glance

Feb 05, 2026

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 05, 2026

    4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROCORTISONE SODIUM SUCCINATE

Strength

EQ 100MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 219856

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 SODIUM SUCCINATE

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.