Orange Book product · Brand (NDA)

ADVIL PM

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Brand (NDA)NDA 021393OTC HALEON US HOLDINGS

View DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN family Open on FDA Orange Book

At a glance

Dec 21, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 21, 2005
20 yr 10 mo ago
Today

Pharmaceutical detail

Active ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021393

Product number

001

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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