Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065488
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;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
05/15/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2017 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/24/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

AZITHROMYCIN

FOR SUSPENSION;ORAL; EQ 100MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065488 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065419 TEVA PHARMS
ZITHROMAX AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER

FOR SUSPENSION;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065488 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065419 TEVA PHARMS
ZITHROMAX AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER

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