Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021214
Company: SUCAMPO PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESCULA UNOPROSTONE ISOPROPYL 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/03/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21214ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21214_Rescula.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-7 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s007.pdf
12/07/2012 SUPPL-6 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021214Orig1s006.pdf
12/05/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2012 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf
12/07/2012 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021214s006s007lbl.pdf
08/03/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21214lbl.pdf

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