Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207960
Company: NEXTWAVE PHARMS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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