Orange Book product · Brand (NDA)

NAPHCON-A

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Brand (NDA)NDA 020226OTC ALCON

View NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE family Open on FDA Orange Book

At a glance

Jun 08, 1994

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 08, 1994
32 yr 6 mo ago
Today

Pharmaceutical detail

Active ingredient

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Strength

0.025%;0.3%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 020226

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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