Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216212
Company: CADILA PHARMS LTD
Company: CADILA PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/21/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
E.E.S. | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 211204 | AMNEAL PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 216212 | CADILA PHARMS LTD |
GRANULE;ORAL; EQ 400MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 211204 | AMNEAL PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 216212 | CADILA PHARMS LTD |