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Orange Book product · Generic (ANDA)

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Generic (ANDA)ANDA 077838TE ABRX HIKMA

At a glance

Jan 17, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 17, 2023

    3 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Strength

3MG/ML;EQ 3MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AB

Application

ANDA 077838

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BETAMETHASONE ACETATE; BETAMETHASONE 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.