Assyro AI

Orange Book product · Generic (ANDA)

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Generic (ANDA)ANDA 076629DISCN DR REDDYS LABS SA

At a glance

Mar 18, 2010

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 18, 2010

    16 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Dosage form

TABLET

Route

ORAL-28

TE code

Not listed

Application

ANDA 076629

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; NORETHINDRONE ACETATE

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.