Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065399
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 500MG 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
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
01/27/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

AZITHROMYCIN

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065509 APOTEX CORP
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065399 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065223 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065212 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065193 TEVA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065405 WOCKHARDT
ZITHROMAX AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription Yes AB 050784 PFIZER

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