Assyro AI

Orange Book product · Generic (ANDA)

SULSTER

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Generic (ANDA)ANDA 074511DISCN EPIC PHARMA LLC

At a glance

Jul 30, 1996

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 30, 1996

    30 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Strength

EQ 0.23% PHOSPHATE;10%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 074511

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 SODIUM PHOSPHATE; 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.