Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209589
Company: FERRING PHARMS INC
Company: FERRING PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLENPIQ | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | 12GM/BOT;3.5GM/BOT;10MG/BOT | SOLUTION;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 |
---|---|---|---|---|---|---|---|
11/28/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209589Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/29/2023 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209589s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209589Orig1s015ltr.pdf | |
08/30/2022 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209589Orig1s014ltr.pdf | |
10/18/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209589Orig1s006ltr.pdf | |
08/08/2019 | SUPPL-5 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209589Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/29/2023 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209589s015lbl.pdf | |
08/30/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.pdf | |
10/18/2019 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf | |
08/08/2019 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s005lbl.pdf | |
11/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf |