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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021493
Company: ALLERGAN

Products on NDA 021493

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYMAR	GATIFLOXACIN	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021493

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.html

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
03/21/2017	SUPPL-9	Efficacy-New Patient Population		Label is not available on this site.
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.

Labels for NDA 021493

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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