Assyro AI

Orange Book product · Generic (ANDA)

EMGEL

ERYTHROMYCIN

Generic (ANDA)ANDA 063107DISCN ALTANA

At a glance

Aug 23, 1991

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 23, 1991

    35 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ERYTHROMYCIN

Strength

2%

Dosage form

GEL

Route

TOPICAL

TE code

Not listed

Application

ANDA 063107

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ERYTHROMYCIN

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.