Assyro AI

Orange Book product · Generic (ANDA)

RISEDRONATE SODIUM

RISEDRONATE SODIUM

Generic (ANDA)ANDA 203822DISCN ZYDUS PHARMS

At a glance

Sep 11, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 11, 2018

    7 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RISEDRONATE SODIUM

Strength

35MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 203822

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of RISEDRONATE SODIUM

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.