Assyro AI

Orange Book product · Generic (ANDA)

LEVOCARNITINE

LEVOCARNITINE

Generic (ANDA)ANDA 075861TE APRX AM REGENT

At a glance

Jun 22, 2001

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 22, 2001

    25 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOCARNITINE

Strength

200MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 075861

Product number

001

Marketing status

RX

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.