Orange Book product · Brand (NDA)

MUCINEX D

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand (NDA)NDA 021585OTC RB HLTH

View GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jun 22, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 22, 2004
22 yr 4 mo ago
Today

Pharmaceutical detail

Active ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Strength

1.2GM;120MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021585

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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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