Assyro AI

Orange Book product · Generic (ANDA)

PROGESTERONE

PROGESTERONE

Generic (ANDA)ANDA 200456TE ABRX SOFGEN PHARMS

At a glance

Sep 28, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 28, 2012

    13 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROGESTERONE

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 200456

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of 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.