Assyro AI

Orange Book product · Generic (ANDA)

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

DEXAMETHASONE SODIUM PHOSPHATE

Generic (ANDA)ANDA 040491TE APRX FRESENIUS KABI USA

At a glance

Apr 11, 2003

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 11, 2003

    23 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Strength

EQ 10MG PHOSPHATE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 040491

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DEXAMETHASONE 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.