Application 208351
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE;EQ 25MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208351-001 | ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | AB | RLD, RS | 2016-03-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N208351-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 |
| N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 |
| N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | ||
| N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension |
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 | 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 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | AB | RLD, RS | 2016-03-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N208351-001 | ODEFSEY | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2016-03-01 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208351-001 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208351-001 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 7390791 | 2025-01-07 | Drug substance, Drug product | 2016-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 7125879 | 2025-04-21 | U-257 | Drug substance, Drug product | 2016-03-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 7390791*PED | 2025-07-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 7390791 | 2025-01-07 | Drug substance, Drug product | 2016-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 7125879 | 2025-04-21 | U-257 | Drug substance, Drug product | 2016-03-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 7390791*PED | 2025-07-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 7390791 | 2025-01-07 | Drug substance, Drug product | 2016-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 7125879 | 2025-04-21 | U-257 | Drug substance, Drug product | 2016-03-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 7390791*PED | 2025-07-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 7390791 | 2025-01-07 | Drug substance, Drug product | 2016-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 7125879 | 2025-04-21 | U-257 | Drug substance, Drug product | 2016-03-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 7390791*PED | 2025-07-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 7390791 | 2025-04-17 | Drug substance, Drug product | 2016-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 7125879 | 2025-04-21 | U-257 | Drug substance, Drug product | 2016-03-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 7390791*PED | 2025-10-17 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 8754065 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-03-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 9296769 | 2032-08-15 | U-257 | Drug substance, Drug product | 2016-04-19 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 8754065*PED | 2033-02-15 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208351-001 | 9296769*PED | 2033-02-15 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208351-001 | 7390791 | 2025-04-17 | Drug substance, Drug product | 2016-03-24 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N208351-001 | M-206 | 2020-08-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208351-001 | M-207 | 2020-08-21 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N208351-001 | NCE | 2020-11-05 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N208351-001 | M-206 | 2020-08-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N208351-001 | M-207 | 2020-08-21 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N208351-001 | NCE | 2020-11-05 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N208351-001 | M-206 | 2020-08-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N208351-001 | M-207 | 2020-08-21 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N208351-001 | NCE | 2020-11-05 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N208351-001 | M-206 | 2020-08-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208351-001 | M-207 | 2020-08-21 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N208351-001 | NCE | 2020-11-05 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N208351-001 | M-206 | 2020-08-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208351-001 | M-207 | 2020-08-21 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N208351-001 | NCE | 2020-11-05 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N208351-001 | M-206 | 2020-08-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208351-001 | M-207 | 2020-08-21 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N208351-001 | NCE | 2020-11-05 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ODEFSEY | EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE | Gilead Sciences, Inc. | ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 208351 NDA208351 61958-2101 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-2340 | ODEFSEY | emtricitabine, rilpivirine, and tenofovir alafenamide | A-S Medication Solutions | NDA | Current |
| 61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | Gilead Sciences, Inc. | NDA | Current |
| 61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | Gilead Sciences, Inc. | NDA | Current |
| 61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | Gilead Sciences, Inc. | NDA | Current |
| 61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | Gilead Sciences, Inc. | NDA | Current |
| 61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | Gilead Sciences, Inc. | NDA | Current |
| 70518-0695 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | REMEDYREPACK INC. | NDA | Current |
| 70518-0695 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81303 | SUPPL | 2025-02-21 |
| 81302 | SUPPL | 2025-02-21 |
| 81294 | SUPPL | 2025-02-20 |
| 81293 | SUPPL | 2025-02-20 |
| 68615 | SUPPL | 2021-09-14 |
| 68597 | SUPPL | 2021-09-13 |
| 66544 | SUPPL | 2021-03-05 |
| 66513 | SUPPL | 2021-03-05 |
| 61164 | SUPPL | 2019-12-05 |
| 61145 | SUPPL | 2019-12-04 |
| 56231 | SUPPL | 2018-11-01 |
| 56220 | SUPPL | 2018-10-31 |
| 49510 | SUPPL | 2017-08-22 |
| 49509 | SUPPL | 2017-08-22 |
| 49503 | SUPPL | 2017-08-22 |
| 49502 | SUPPL | 2017-08-22 |
| 47986 | SUPPL | 2017-04-12 |
| 47907 | SUPPL | 2017-04-10 |
| 46008 | ORIG | 2016-12-02 |
| 32907 | ORIG | 2016-03-03 |
| 19992 | ORIG | 2016-03-03 |
| 52461 | ORIG | 1900-01-01 |
| 52460 | ORIG | 1900-01-01 |
| 52459 | ORIG | 1900-01-01 |
| 52458 | ORIG | 1900-01-01 |