Assyro AI

Orange Book product · Brand (NDA)

LO LOESTRIN FE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand (NDA)NDA 022501RX APIL

At a glance

Oct 21, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

1

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 21, 2010

    15 yr 11 mo ago

  2. Today

  3. Patent 7704984 expires

    Listed method-of-use patent (U-1090) expiration.

    Feb 02, 2029

    in 2 yr 8 mo

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.01MG,0.01MG;1MG,N/A

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022501

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7704984Feb 02, 2029in 2 yr 8 mo
U-1090
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.