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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207960
Company: NEXTWAVE PHARMS

Medication Guide

Products on NDA 207960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	Prescription	None	Yes	No
QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	Prescription	None	Yes	No
QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207960s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207960Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207960Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207960orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207960Orig1s016; 202100Orig1s023ltr.pdf
06/25/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207960s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202100Orig1s018; 207960Orig1s012ltr.pdf
02/28/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207960Orig1s005ltr.pdf
01/04/2017	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202100Orig1s012,207960Orig1s004ltr.pdf

Labels for NDA 207960

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207960orig1s016lbl.pdf
10/13/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207960orig1s016lbl.pdf
06/25/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207960s012lbl.pdf
02/28/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf
01/04/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s004lbl.pdf
12/04/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207960s000lbl.pdf

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