Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA064067 1994-07-29 Ophthalmic RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For The Treatment Of Superficial Ocular Infections Involving The Conjunctiva And/or Cornea Caused By Organisms Susceptible To Erythromycin. For Prophylaxis Of Ophthalmia Neonatorum Due To N. Gonorrhoeae Or C. Trachomatis. The Effectiveness Of Erythromycin In The Prevention Of Ophthalmia Caused By Penicillinase-Producing N. Gonorrhoeae Is Not Established. For Infants Born To Mothers With Clinically Apparent Gonorrhea, Intravenous Or Intramuscular Injections Of Aqueous Crystalline Penicillin G Should Be Given; A Single Dose Of 50,000 Units For Term Infants Or 20,000 Units For Infants Of Low Birth Weight. Topical Prophylaxis Alone Is Inadequate For These Infants.

All Formulated Excipients (0 Total)


Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Erythromycin ERYTHROMYCIN ZINC85534336