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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216984
Company: SHORLA

Products on NDA 216984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEPYLUTE	THIOTEPA	15MG/1.5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TEPYLUTE	THIOTEPA	100MG/10ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216984s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216984Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216984Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2025	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216984Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216984Orig1s005ltr.pdf
02/26/2025	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216984Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216984Orig1s001ltr.pdf

Labels for NDA 216984

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216984Orig1s005lbl.pdf
12/09/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216984Orig1s005lbl.pdf
02/26/2025	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216984Orig1s001lbl.pdf
06/25/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216984s000lbl.pdf

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