Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209363
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOLOSEC | SECNIDAZOLE | 2GM/PACKET | GRANULE;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 |
---|---|---|---|---|---|---|---|
09/15/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209363Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209363Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2021 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209363Orig1s017ltr.pdf | |
01/26/2022 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209363Orig1s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209363Orig1s014, s016ltr.pdf | |
06/14/2021 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209363Orig1s015ltr.pdf | |
01/26/2022 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209363Orig1s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/!209363Orig1s014, s016ltr.pdf | |
06/30/2021 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209363Orig1s012ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/26/2022 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209363Orig1s014s016lbl.pdf | |
01/26/2022 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209363Orig1s014s016lbl.pdf | |
12/15/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s017lbl.pdf | |
12/15/2021 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s017lbl.pdf | |
06/30/2021 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s012lbl.pdf | |
06/14/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s015lbl.pdf | |
06/14/2021 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209363s015lbl.pdf | |
09/15/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf |