Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207960
Company: NEXTWAVE PHARMS
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 |
---|---|---|---|---|---|
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 |
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 |