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Orange Book product · Generic (ANDA)

PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE SODIUM PHOSPHATE

Generic (ANDA)ANDA 203559TE AARX EDENBRIDGE PHARMS

At a glance

Dec 20, 2016

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2016

    9 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PREDNISOLONE SODIUM PHOSPHATE

Strength

EQ 10MG BASE/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 203559

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PREDNISOLONE SODIUM PHOSPHATE

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.