Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204736
Company: AVADEL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACIPHEX SPRINKLE RABEPRAZOLE SODIUM 5MG CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
ACIPHEX SPRINKLE RABEPRAZOLE SODIUM 10MG CAPSULE, DELAYED RELEASE;ORAL 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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English