Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202020
Company: HORIZON PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAYOS PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
RAYOS PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
RAYOS PREDNISONE 5MG TABLET, DELAYED RELEASE;ORAL Prescription AB 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
07/26/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202020s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202020Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020_rayos_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/05/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/12/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/10/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/12/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/25/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/13/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202020s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202020Orig1s003ltr.pdf
03/13/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/13/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202020s003lbl.pdf
07/26/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202020s000lbl.pdf

RAYOS

TABLET, DELAYED RELEASE;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA

TABLET, DELAYED RELEASE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA

TABLET, DELAYED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 5MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 5MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA

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