Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022206
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAPAFLO SILODOSIN 4MG CAPSULE;ORAL Prescription AB Yes Yes
RAPAFLO SILODOSIN 8MG CAPSULE;ORAL Prescription AB Yes 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
10/08/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022206lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022206s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/12/2013 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022206s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022206Orig1s012ltr.pdf
06/24/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/21/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/14/2012 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022206Orig1s008ltr.pdf
03/04/2010 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022206s006ltr.pdf
02/13/2009 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022206s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2013 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022206s012lbl.pdf
12/14/2012 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022206s008lbl.pdf
03/04/2010 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022206s006lbl.pdf
02/13/2009 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf
02/13/2009 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022206s001lbl.pdf
10/08/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022206lbl.pdf

RAPAFLO

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 4MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN SALES LLC
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

CAPSULE;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 8MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN SALES LLC
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

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