Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065398
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 250MG 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 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065507 APOTEX CORP
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065398 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065225 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065211 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065153 TEVA
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065404 WOCKHARDT
ZITHROMAX AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription Yes AB 050711 PFIZER

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