Assyro AI

Orange Book product · Brand (NDA)

AKTIPAK

BENZOYL PEROXIDE; ERYTHROMYCIN

Brand (NDA)NDA 050769DISCN BIOFRONTERA
View BENZOYL PEROXIDE; ERYTHROMYCIN familyOpen on FDA Orange Book

At a glance

Nov 27, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 27, 2000

    25 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BENZOYL PEROXIDE; ERYTHROMYCIN

Strength

5%;3%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

NDA 050769

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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