Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021598
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIGAMOX MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT1 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/15/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-598_Vigamox.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2017 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021598Orig1s022ltr.pdf
10/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021598s017ltr.pdf
06/25/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf
10/03/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf
04/12/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf
10/03/2003 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf
03/14/2017 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021598s022lbl.pdf
10/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf
06/25/2004 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf
04/12/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf
10/03/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf
10/03/2003 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf
04/15/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf

VIGAMOX

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202916 AKORN
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 209469 ALEMBIC PHARMS LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 090080 APOTEX
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 206242 AUROBINDO PHARMA LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202867 LUPIN LTD
MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT1 202525 WATSON LABS INC
VIGAMOX MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT1 021598 NOVARTIS

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