Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202100
Company: NEXTWAVE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUILLIVANT XR METHYLPHENIDATE HYDROCHLORIDE 5MG/ML FOR SUSPENSION, EXTENDED 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
09/27/2012 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/2012/202100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202100Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100_quillivantxr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s012,207960Orig1s004ltr.pdf
05/27/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/13/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202100s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202100Orig1s007ltr.pdf
01/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s006ltr.pdf
07/13/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s005ltr.pdf
04/17/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s004ltr.pdf
12/12/2013 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s003ltr.pdf
08/09/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s002ltr.pdf
05/15/2013 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s006lbl.pdf
01/04/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf
05/13/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202100s007lbl.pdf
07/13/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100Orig1s005lbl.pdf
04/17/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100s004lbl.pdf
12/12/2013 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s003lbl.pdf
08/09/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s002lbl.pdf
05/15/2013 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s001lbl.pdf
09/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202100lbl.pdf

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