Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215290
Company: NEXUS
Company: NEXUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/14/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ERYTHROMYCIN LACTOBIONATE
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYTHROCIN | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050609 | HOSPIRA |
ERYTHROCIN | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062638 | HOSPIRA |
ERYTHROMYCIN LACTOBIONATE | ERYTHROMYCIN LACTOBIONATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215290 | NEXUS |