Assyro AI

Orange Book product · Generic (ANDA)

ORTHO-EST

ESTROPIPATE

Generic (ANDA)ANDA 089582DISCN SUN PHARM INDS INC

At a glance

Jul 17, 1991

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 17, 1991

    35 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTROPIPATE

Strength

1.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 089582

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESTROPIPATE

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.