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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209363
Company: LUPIN

Products on NDA 209363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLOSEC	SECNIDAZOLE	2GM/PACKET	GRANULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209363

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

Labels for NDA 209363

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

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