Assyro AI

Orange Book product · Generic (ANDA)

BLEPHAMIDE S.O.P.

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Generic (ANDA)ANDA 087748DISCN ALLERGAN

At a glance

Dec 03, 1986

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 03, 1986

    40 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Strength

0.2%;10%

Dosage form

OINTMENT

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 087748

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.