Home Applications 208464 Application 208464
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VEMLIDY TENOFOVIR ALAFENAMIDE FUMARATE TABLET;ORAL EQ 25MG BASE Yes Yes
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 N208464-001 VEMLIDY TENOFOVIR ALAFENAMIDE FUMARATE EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208464-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 N208464-001 8754065 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 N208464-001 9296769 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 N208464-001 9296769 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 N208464-001 9296769 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 N208464-001 8754065*PED 2033-02-15 Pediatric extension N208464-001 9296769*PED 2033-02-15 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208464-001 NPP 2027-03-27
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.
Product history page 1 of 2 · 42 observed 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 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL AB RLD, RS 2016-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208464-001 VEMLIDY EQ 25MG BASE TABLET / ORAL RLD, RS 2016-11-10 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 9 · 322 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 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 8754065 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 9296769 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 9296769 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 9296769 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 8754065*PED 2033-02-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208464-001 9296769*PED 2033-02-15 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 8754065 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 9296769 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 9296769 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 9296769 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208464-001 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 7390791 2025-01-07 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 8754065 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 9296769 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 9296769 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 9296769 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208464-001 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208464-001 7390791 2025-01-07 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 7390791*PED 2025-07-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 8754065 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 9296769 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 9296769 2032-08-15 U-3880 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 9296769 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 8754065*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208464-001 9296769*PED 2033-02-15 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208464-001 7390791 2025-01-07 Drug substance, Drug product 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208464-001 7390791*PED 2025-07-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208464-001 8754065 2032-08-15 U-999 Drug substance, Drug product 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208464-001 8754065 2032-08-15 U-1275 Drug substance, Drug product 2016-11-28 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 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 VEMLIDY TENOFOVIR ALAFENAMIDE Gilead Sciences, Inc. 72e6b33c-0351-4070-9172-eeaa186c01d2 2025-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208464 application number: NDA208464 ndc (product): 61958-2301
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current 61958-2301 VEMLIDY tenofovir alafenamide Gilead Sciences, Inc. NDA Current