Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020193
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELMIRON PENTOSAN POLYSULFATE SODIUM 100MG CAPSULE;ORAL 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
09/26/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020193Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/2020 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020193Orig1s014ltr.pdf
12/12/2008 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s009ltr.pdf
07/24/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s007ltr.pdf
09/20/2006 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020193s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020193s004ltr.pdf
08/24/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20193s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20193s003ltr.pdf
11/08/2001 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020193Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2020 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf
12/12/2008 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf
07/24/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s007lbl.pdf
09/20/2006 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020193s004lbl.pdf
08/24/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20193s003lbl.pdf

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