Home Applications 021896 Application 021896
Type NDA
Sponsor GILEAD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMTRIVA EMTRICITABINE SOLUTION;ORAL 10MG/ML Yes Yes 002 EMTRIVA EMTRICITABINE SOLUTION; ORAL 10MG/ML No 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 N021896-001 EMTRIVA EMTRICITABINE 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28
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 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021896-001 6642245 2020-11-04 U-257 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6703396 2021-03-09 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6642245*PED 2021-05-04 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6703396*PED 2021-09-09 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021896-001 6703396 2021-03-09 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021896-001 6642245*PED 2021-05-04 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021896-001 6703396*PED 2021-09-09 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021896-001 6642245 2020-11-04 U-257 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021896-001 6642245 2020-11-04 U-257 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6703396 2021-03-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6642245*PED 2021-05-04 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6703396*PED 2021-09-09 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021896-001 6642245 2020-11-04 U-257 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021896-001 6642245 2020-11-04 U-257 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6703396 2021-03-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6642245*PED 2021-05-04 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6703396*PED 2021-09-09 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021896-001 6642245 2020-11-04 U-257 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6703396 2021-03-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6642245*PED 2021-05-04 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6703396*PED 2021-09-09 Pediatric extension ea99ee380514…
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 Emtriva EMTRICITABINE Gilead Sciences, Inc. d6599395-3944-44f9-97f2-e0424c6b6a1f 2025-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021896 application number: NDA021896 ndc (product): 61958-0602
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-0602 Emtriva EMTRICITABINE Gilead Sciences, Inc. NDA Current 61958-0602 Emtriva EMTRICITABINE Gilead Sciences, Inc. NDA Current 61958-0602 Emtriva EMTRICITABINE Gilead Sciences, Inc. NDA Current