Assyro AI

Orange Book product · Generic (ANDA)

CUPRIC SULFATE

CUPRIC SULFATE

Generic (ANDA)ANDA 216324RX AM REGENT

At a glance

Dec 16, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 16, 2022

    3 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CUPRIC SULFATE

Strength

EQ 0.4MG COPPER/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 216324

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CUPRIC SULFATE

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.