Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065419
Company: TEVA PHARMS
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
06/24/2008 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
03/19/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/26/2013 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/18/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/29/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/04/2010 SUPPL-3 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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