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Orange Book product · Brand (NDA)

SINGULAIR

MONTELUKAST SODIUM

Brand (NDA)NDA 021409DISCN ORGANON
View MONTELUKAST SODIUM familyOpen on FDA Orange Book

At a glance

Jul 26, 2002

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 2002

    24 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MONTELUKAST SODIUM

Strength

EQ 4MG BASE/PACKET

Dosage form

GRANULE

Route

ORAL

TE code

Not listed

Application

NDA 021409

Product number

001

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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