Assyro AI

Orange Book product · Generic (ANDA)

HER STYLE

LEVONORGESTREL

Generic (ANDA)ANDA 207976OTC NOVAST LABS

At a glance

Mar 11, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 11, 2016

    10 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVONORGESTREL

Strength

1.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 207976

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVONORGESTREL

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.