Assyro AI

Orange Book product · Generic (ANDA)

PROGESTERONE

PROGESTERONE

Generic (ANDA)ANDA 075906TE AORX FRESENIUS KABI USA

At a glance

Apr 25, 2001

Approved

Generic (ANDA)

Application

AO

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 25, 2001

    25 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROGESTERONE

Strength

50MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AO

Application

ANDA 075906

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.