Home Applications 216984 Application 216984
Type NDA
Sponsor SHORLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEPYLUTE THIOTEPA SOLUTION;INTRAVENOUS 15MG/1.5ML (10MG/ML) Yes Yes 002 TEPYLUTE THIOTEPA SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216984-001 TEPYLUTE THIOTEPA 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 N216984-002 TEPYLUTE THIOTEPA 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216984-001 11975013 2041-08-16 Drug product 2024-07-25 N216984-001 12622921 2041-08-16 U-4530 2026-06-10 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 N216984-002 12622921 2041-08-16 U-4530 2026-06-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216984-002 TEPYLUTE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216984-002 TEPYLUTE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216984-002 TEPYLUTE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216984-002 TEPYLUTE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-001 TEPYLUTE 15MG/1.5ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-06-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-002 TEPYLUTE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-26 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216984-001 12622921 2041-08-16 U-4530 2026-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216984-002 12622921 2041-08-16 U-4530 2026-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-001 11975013 2041-08-16 Drug product 2024-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-001 12622921 2041-08-16 U-4530 2026-06-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-002 11975013 2041-08-16 Drug product 2025-03-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216984-002 12622921 2041-08-16 U-4530 2026-06-10 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TEPYLUTE THIOTEPA Shorla Oncology Inc. add44e98-a042-4e38-b870-beb36693805b 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216984 application number: NDA216984
Documents# Document, Submission type, Date table Document Submission type Date 84373 SUPPL 2026-04-20 84374 SUPPL 2026-01-23 82187 ORIG 2025-05-15 81378 SUPPL 2025-02-27 81377 SUPPL 2025-02-27 78903 ORIG 2024-06-26