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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050790
Company: ABBVIE

Products on NDA 050790

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RESTASIS	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	AB	Yes	Yes
RESTASIS MULTIDOSE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050790

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2002	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-023_Restasis.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050790Orig1s027ltr.pdf
10/27/2016	SUPPL-25	Labeling-Package Insert	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/50790Orig1s025.pdf
10/27/2016	SUPPL-24	Manufacturing (CMC)	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/50790Orig1s024.pdf
12/05/2013	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
01/16/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
05/31/2013	SUPPL-21	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf
12/03/2012	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050790Orig1s020ltr.pdf
01/16/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/27/2007	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
10/01/2003	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf
10/01/2003	SUPPL-3	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf
09/12/2003	SUPPL-2	Manufacturing (CMC)	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050790_S002_RestasisTOC.cfm
09/16/2003	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790slr001ltr.pdf

Labels for NDA 050790

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf
10/27/2016	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf
10/27/2016	SUPPL-24	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf
05/31/2013	SUPPL-21	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf
12/03/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf
09/16/2003	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.pdf
12/23/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf

Therapeutic Equivalents for NDA 050790

RESTASIS

EMULSION;OPHTHALMIC; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	207606	APOTEX
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	209811	DEVA HOLDING AS
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	205894	MYLAN
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211943	SAPTALIS PHARMS
RESTASIS	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	Yes	AB	050790	ABBVIE

RESTASIS MULTIDOSE

There are no Therapeutic Equivalents.

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