Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021079
Company: SANTEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALAMAST PEMIROLAST POTASSIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Discontinued None No 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
09/24/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21079ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21079_Alamast.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/15/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/12/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf
05/12/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021079s006,008ltr.pdf
05/03/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/26/2000 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
05/12/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf
05/12/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021079s006,008lbl.pdf
09/24/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21079lbl.pdf

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