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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020193
Company: JANSSEN PHARMS

Medication Guide

Products on NDA 020193

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020193

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
03/12/2021	SUPPL-15	Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020193Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020193Orig1s015.pdf
06/16/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020193s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020193Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/020193Orig1s014.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

Labels for NDA 020193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2021	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193Orig1s015lbl.pdf
03/12/2021	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193Orig1s015lbl.pdf
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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