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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205394
Company: GENSCO

Products on NDA 205394

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIZAFILM	RIZATRIPTAN BENZOATE	EQ 10MG BASE	FILM;ORAL	Discontinued	None	Yes	No
RIZAFILM	RIZATRIPTAN BENZOATE	EQ 5MG BASE	FILM;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205394Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205394Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2026	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205394Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205394Orig1s007ltr.pdf
02/26/2026	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205394s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205394Orig1s005ltr.pdf
12/11/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205394Orig1s002ltr.pdf

Labels for NDA 205394

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2026	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205394s005lbl.pdf
01/29/2026	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205394Orig1s007lbl.pdf
12/11/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf
12/11/2023	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s002lbl.pdf
04/14/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205394s000lbl.pdf

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