Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202632
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG 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
03/04/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202632Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/05/2019 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/05/2019 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/05/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/05/2019 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/05/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/05/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

MOXIFLOXACIN HYDROCHLORIDE

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 202632 AUROBINDO PHARMA LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 205348 CROSSMEDIKA SA
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 076938 DR REDDYS LABS LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 208682 MSN
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 207285 NOVEL LABS INC
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 077437 TEVA PHARMS USA
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Prescription No AB 200160 TORRENT

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