Assyro AI

Orange Book product · Generic (ANDA)

ESTRADIOL AND PROGESTERONE

ESTRADIOL; PROGESTERONE

Generic (ANDA)ANDA 214293DISCN AMNEAL PHARMS

At a glance

May 16, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 16, 2022

    4 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL; PROGESTERONE

Strength

1MG;100MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 214293

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESTRADIOL; PROGESTERONE

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.