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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202020
Company: HORIZON

Summary Review

Products on NDA 202020

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202020

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
12/27/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202020s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202020Orig1s012ltr.pdf
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.

Labels for NDA 202020

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202020s012lbl.pdf
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

Therapeutic Equivalents for NDA 202020

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

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

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

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