Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202100
Company: NEXTWAVE
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 | AB | 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 |
---|---|---|---|---|---|
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 |
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 |
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 |