Assyro AI

Orange Book product · Generic (ANDA)

LEVOCARNITINE

LEVOCARNITINE

Generic (ANDA)ANDA 077399DISCN HIKMA

At a glance

Oct 25, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 25, 2007

    18 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOCARNITINE

Strength

1GM/10ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 077399

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVOCARNITINE

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.