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Drugs@FDA: FDA-Approved Drugs

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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.cfm 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
07/29/2016	SUPPL-16	Labeling-Package Insert, Labeling-Container/Carton Labels	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
07/29/2016	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf
07/29/2016	SUPPL-16	Labeling-Container/Carton Labels	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	211776	CIPLA
DIFLUPREDNATE	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	214894	DR REDDYS
DUREZOL	DIFLUPREDNATE	0.05%	EMULSION;OPHTHALMIC	Prescription	Yes	AB	022212	SANDOZ

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