Assyro AI

Orange Book product · Generic (ANDA)

TRI-PREVIFEM

ETHINYL ESTRADIOL; NORGESTIMATE

Generic (ANDA)ANDA 076335DISCN PH HEALTH

At a glance

Mar 26, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 26, 2004

    22 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Dosage form

TABLET

Route

ORAL-28

TE code

Not listed

Application

ANDA 076335

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ETHINYL ESTRADIOL; NORGESTIMATE

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.