Treats infections caused by susceptible strains of the designated organisms in the…. ANDA 211204, held by Amneal Pharms. Erythromycin Ethylsuccinate.
As of Nov 15, 2026, ANDA 211204 (Erythromycin Ethylsuccinate), held by Amneal Pharms, was first approved by FDA on Nov 1, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2019 | Original application | Approved | None posted |
| Erythromycin EthylsuccinateEQ 200MG BASE/5ML · granule;oral | Erythromycin Ethylsuccinate | Rx |
| Erythromycin EthylsuccinateEQ 400MG BASE/5ML · granule;oral | Erythromycin Ethylsuccinate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
