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Orange Book product · Generic (ANDA)

DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE

Generic (ANDA)ANDA 215654TE APRX GLAND

At a glance

Aug 04, 2021

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 04, 2021

    4 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Strength

EQ 4MG PHOSPHATE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 215654

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.