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Orange Book product · Brand (NDA)

BENZAMYCIN

BENZOYL PEROXIDE; ERYTHROMYCIN

Brand (NDA)NDA 050557TE ABRX VALEANT INTL
View BENZOYL PEROXIDE; ERYTHROMYCIN familyOpen on FDA Orange Book

At a glance

Oct 26, 1984

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 26, 1984

    42 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BENZOYL PEROXIDE; ERYTHROMYCIN

Strength

5%;3%

Dosage form

GEL

Route

TOPICAL

TE code

AB

Application

NDA 050557

Product number

001

Marketing status

RX

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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