Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021493
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYMAR GATIFLOXACIN 0.3% SOLUTION/DROPS;OPHTHALMIC Prescription None 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
03/28/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21493_Zymar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21493ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021493_Zymar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021493s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021493Orig1s011ltr.pdf
05/21/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021493s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021493Orig1s010ltr.pdf
06/20/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf
06/20/2005 SUPPL-6 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021493s006,007ltr.pdf
07/23/2004 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021493s011lbl.pdf
05/21/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021493s010lbl.pdf
06/20/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf
06/20/2005 SUPPL-6 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021493s006,007lbl.pdf
03/28/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21493_Zymar_lbl.pdf

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