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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204736
Company: AYTU

Medication Guide

Products on NDA 204736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	5MG	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	10MG	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2013	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204736Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204736_aciphex_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204736Orig1s012ltr.pdf
06/07/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204736Orig1s010ltr.pdf
07/27/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204736s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204736Orig1s008ltr.pdf
10/24/2016	SUPPL-7	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204736Orig1s007ltr.pdf
10/13/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/19/2014	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf
10/15/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf
04/04/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf
08/28/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204736

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf
06/07/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf
07/27/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204736s008lbl.pdf
04/04/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf
12/19/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf
12/19/2014	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf
10/15/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf
03/26/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf

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