Assyro AI

Orange Book product · Generic (ANDA)

MEGESTROL ACETATE

MEGESTROL ACETATE

Generic (ANDA)ANDA 203139RX TWI PHARMS

At a glance

Aug 27, 2014

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 27, 2014

    12 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

MEGESTROL ACETATE

Strength

125MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 203139

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of MEGESTROL 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.