Assyro AI

Orange Book product · Brand (NDA)

PREMPHASE (PREMARIN;CYCRIN 14/14)

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Brand (NDA)NDA 020303DISCN WYETH PHARMS INC

At a glance

Dec 30, 1994

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 30, 1994

    31 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

Strength

0.625MG,0.625MG;N/A,5MG

Dosage form

TABLET

Route

ORAL-28

TE code

Not listed

Application

NDA 020303

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.