An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022212
Company: SANDOZ

Summary Review

Products on NDA 022212

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUREZOL	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022212

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022212s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2025	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022212s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022212Orig1s025ltr.pdf
07/15/2025	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022212Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022212Orig1s018ltr.pdf
07/29/2016	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022212Orig1s016ltr.pdf
04/11/2016	SUPPL-15	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022212Orig1s015.pdf
05/15/2013	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s012ltr.pdf
03/22/2013	SUPPL-11	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s011ltr.pdf
11/27/2012	SUPPL-10	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212Orig1s010ltr.pdf
06/13/2012	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212s003ltr.pdf
03/20/2009	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022212s001ltr.pdf

Labels for NDA 022212

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2025	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022212s025lbl.pdf
07/15/2025	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022212Orig1s018lbl.pdf
07/29/2016	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
07/29/2016	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
05/15/2013	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf
03/22/2013	SUPPL-11	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf
11/27/2012	SUPPL-10	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf
06/13/2012	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf
06/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf

Therapeutic Equivalents for NDA 022212

DUREZOL

EMULSION;OPHTHALMIC; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211526	AMNEAL
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	219441	CAPLIN
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211776	CIPLA
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	214894	DR REDDYS
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	207284	EPIC PHARMA LLC
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	212566	MYLAN LABS LTD
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	218191	UPSHER SMITH LABS
DUREZOL	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	Yes	AB	022212	SANDOZ

Top