Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022548
Company: ABBVIE

• Summary Review

Products on NDA 022548

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYMAXID	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022548s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022548s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022548s000_zymaxid_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022548s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022548Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/022548Orig1s002.pdf
03/12/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022548

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022548s002lbl.pdf
05/18/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022548s000lbl.pdf

Therapeutic Equivalents for NDA 022548

ZYMAXID

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GATIFLOXACIN	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202653	LUPIN LTD
GATIFLOXACIN	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204227	SANDOZ
ZYMAXID	GATIFLOXACIN	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	022548	ABBVIE