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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202100
Company: NEXTWAVE

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 202100

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	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202100

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
10/13/2023	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202100Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207960Orig1s016; 202100Orig1s023ltr.pdf
06/25/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202100s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202100Orig1s018; 207960Orig1s012ltr.pdf
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

Labels for NDA 202100

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202100Orig1s023lbl.pdf
10/13/2023	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202100Orig1s023lbl.pdf
06/25/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202100s018lbl.pdf
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

Therapeutic Equivalents for NDA 202100

QUILLIVANT XR

FOR SUSPENSION, EXTENDED RELEASE;ORAL; 5MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	No	AB	206049	ACTAVIS LABS FL INC
QUILLIVANT XR	METHYLPHENIDATE HYDROCHLORIDE	5MG/ML	FOR SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202100	NEXTWAVE

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