Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050790
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESTASIS CYCLOSPORINE 0.05% EMULSION;OPHTHALMIC Prescription None Yes Yes
RESTASIS MULTIDOSE CYCLOSPORINE 0.05% EMULSION;OPHTHALMIC Prescription None Yes Yes
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
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

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