Assyro AI

Orange Book product · Brand (NDA)

ESKALITH CR

LITHIUM CARBONATE

Brand (NDA)NDA 018152DISCN JDS PHARMS

At a glance

Mar 29, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 29, 1982

    44 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LITHIUM CARBONATE

Strength

450MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 018152

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.