Assyro AI

Orange Book product · Brand (NDA)

ACTONEL

RISEDRONATE SODIUM

Brand (NDA)NDA 020835DISCN APIL
View RISEDRONATE SODIUM familyOpen on FDA Orange Book

At a glance

Apr 14, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 14, 2000

    26 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RISEDRONATE SODIUM

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020835

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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.

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