Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021737
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RETISERT FLUOCINOLONE ACETONIDE 0.59MG IMPLANT;INTRAVITREAL 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
11/04/2004 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021737ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021737s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/20/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/02/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021737s019ltr.pdf
11/30/2010 SUPPL-18 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021737s018ltr.pdf
08/05/2008 SUPPL-10 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021737s010ltr.pdf
10/30/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021737s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf
10/30/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021737s007lbl.pdf
11/04/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021737lbl.pdf

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