Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211204
Company: AMNEAL PHARMS
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
11/01/2019 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 ARBOR PHARMS LLC
ERYPED ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE;ORAL Prescription Yes AB 050207 ARBOR PHARMS LLC
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 INC
ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE;ORAL Prescription No AB 062055 ANI PHARMS INC
ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML GRANULE;ORAL Prescription No AB 211991 PAR PHARM INC

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 ARBOR PHARMS LLC
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 INC
ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML GRANULE;ORAL Prescription No AB 211991 PAR PHARM INC

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