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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211793
Company: ALEMBIC PHARMS LTD
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
01/27/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2022 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/22/2021 SUPPL-5 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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