Home Applications 021449 Application 021449
Type NDA
Sponsor GILEAD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HEPSERA ADEFOVIR DIPIVOXIL TABLET;ORAL 10MG Yes Yes
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date N021449-001 HEPSERA ADEFOVIR DIPIVOXIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, RS 2002-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, RS 2002-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, RS 2002-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, RS 2002-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021449-001 HEPSERA 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL AB RLD, RS 2002-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021449-001 HEPSERA 10MG TABLET / ORAL AB RLD, RS 2002-09-20 cb3db0bc1861…
Observed Orange Book normalized TE 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 46014-0501 Hepsera Adefovir Dipivoxil Excella GmbH NDA Current 61958-0501 Hepsera adefovir dipivoxil Gilead Sciences, Inc. NDA Current 61958-0501 Hepsera adefovir dipivoxil Gilead Sciences, Inc. NDA Current 61958-0501 Hepsera adefovir dipivoxil Gilead Sciences, Inc. NDA Current