Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021479
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZELAPAR SELEGILINE HYDROCHLORIDE 1.25MG TABLET, ORALLY DISINTEGRATING;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
06/14/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021479s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/31/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021479Orig1s005ltr.pdf
12/31/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf
12/31/2008 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021479s003,021479s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021479s005lbl.pdf
12/31/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf
12/31/2008 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021479s003s004lbl.pdf
06/14/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021479lbl.pdf

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