Home Applications 202123 Application 202123
Type NDA
Sponsor GILEAD SCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COMPLERA EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 200MG;EQ 25MG BASE;300MG 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 N202123-001 COMPLERA EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202123-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202123-001 10857102 2033-01-14 Drug product 2021-01-06
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 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202123-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202123-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 341 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 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 8592397 2024-01-13 U-257 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 8592397 2024-01-13 U-257 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 8592397 2024-01-13 U-257 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 8592397 2024-01-13 U-257 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 d8e5a09893c0…
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 COMPLERA EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE Gilead Sciences, Inc. d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 2025-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202123 application number: NDA202123 ndc (product): 61958-1101
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-1248 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate A-S Medication Solutions NDA Current 61958-1101 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1101 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1101 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 61958-1101 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Gilead Sciences, Inc. NDA Current 70518-0677 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate REMEDYREPACK INC. NDA Current 70518-0677 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate REMEDYREPACK INC. NDA Current 70518-0677 COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate REMEDYREPACK INC. NDA Current