Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202535
Company: FERRING PHARMS INC
Company: FERRING PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREPOPIK | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/16/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202535Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535_prepopik_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/29/2023 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202535s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202535Orig1s006ltr.pdf | |
| 08/15/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202535Orig1s005ltr.pdf | |
| 05/06/2016 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/29/2023 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202535s006lbl.pdf | |
| 08/15/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf | |
| 07/16/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf |