Home Applications 214461 Application 214461
Type NDA
Sponsor CHIMERIX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEMBEXA BRINCIDOFOVIR TABLET; ORAL SUSPENSION 10MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N214461-001 TEMBEXA BRINCIDOFOVIR 100MG TABLET / ORAL RLD, RS 2021-06-04
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 N214461-001 9303051 2034-07-30 U-3165 Drug substance, Drug product 2021-07-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214461-001 ODE-354 2028-06-04
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 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 170 observed states.
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 N214461-001 9303051 2034-07-30 U-3165 Drug substance, Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 61 observed states.
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 Tembexa BRINCIDOFOVIR Emergent BioDefense Operations Lansing LLC 209aa94b-c613-4880-ad89-41be83d12c0a 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214461 application number: NDA214461
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 79622-010 Tembexa Brincidofovir Chimerix, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69803 ORIG 2022-01-03 68290 SUPPL 2021-08-04 68281 SUPPL 2021-08-04 67761 ORIG 2021-06-11 67728 ORIG 2021-06-07