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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065302
Company: ATLANTIDE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;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
02/11/2008 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
11/22/2021 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/08/2020 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/08/2020 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/08/2020 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/05/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

AZITHROMYCIN

TABLET;ORAL; EQ 600MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 211793 ALEMBIC PHARMS LTD
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065302 ATLANTIDE
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 209999 BIONPHARMA INC
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 207566 CSPC OUYI
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065400 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065218 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065209 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 209043 SUNSHINE
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 211068 YUNG SHIN PHARM
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