Home Applications 214518 Application 214518
Type NDA
Sponsor SIGA TECHNOLOGIES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TPOXX TECOVIRIMAT SOLUTION;INTRAVENOUS 200MG/20ML (10MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214518-001 TPOXX TECOVIRIMAT 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214518-001 8039504 2027-07-23 Drug product 2022-06-10 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 N214518-001 7737168 2031-09-04 U-3377 2022-06-10
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 2026-02-19 14:30 UTC 2026-02 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 202 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8530509 2024-06-18 Drug product 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8802714 2024-06-18 U-3377 2022-06-10 5bbf6a4d5a75…
Observed Orange Book exclusivity history# 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 TPOXX TECOVIRIMAT MONOHYDRATE SIGA Technologies, Inc. fce826ab-4d6a-4139-a2ee-a304a913a253 2025-12-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 214518 application number: NDA214518 ndc (product): 50072-010
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50072-010 TPOXX tecovirimat monohydrate SIGA Technologies, Inc. NDA Current 50072-010 TPOXX tecovirimat monohydrate SIGA Technologies, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78628 SUPPL 2024-07-02 78626 SUPPL 2024-06-04 71846 ORIG 2022-08-18 71105 ORIG 2022-05-20 71097 ORIG 2022-05-19