Assyro AI

Orange Book product · Generic (ANDA)

PREDAMIDE

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Generic (ANDA)ANDA 088059DISCN EPIC PHARMA LLC

At a glance

Jul 29, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 29, 1983

    43 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Strength

0.5%;10%

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 088059

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

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.