Assyro AI

Orange Book product · Generic (ANDA)

METHYLPREDNISOLONE

METHYLPREDNISOLONE SODIUM SUCCINATE

Generic (ANDA)ANDA 087535DISCN ORGANON USA INC

At a glance

Jun 25, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 25, 1982

    44 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Strength

EQ 1GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 087535

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METHYLPREDNISOLONE 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.