Application 021356
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | Yes | Yes |
| 002 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 150MG | Yes | No |
| 003 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG | Yes | No |
| 004 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 250MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021356-001 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 |
| N021356-002 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 |
| N021356-003 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 |
| N021356-004 | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021356-001 | AB |
| N021356-002 | AB |
| N021356-003 | AB |
| N021356-004 | AB |
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 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-001 | VIREAD | 300MG | TABLET / ORAL | AB | RLD, RS | 2001-10-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-002 | VIREAD | 150MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-003 | VIREAD | 200MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-004 | VIREAD | 250MG | TABLET / ORAL | AB | RLD | 2012-01-18 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021356-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021356-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021356-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021356-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021356-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021356-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021356-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021356-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021356-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021356-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021356-004 | AB | 1 | d06236e962d9… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021356-001 | PED | 2022-06-11 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021356-002 | PED | 2022-06-11 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021356-003 | PED | 2022-06-11 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021356-004 | PED | 2022-06-11 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021356-001 | PED | 2022-06-11 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021356-002 | PED | 2022-06-11 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021356-003 | PED | 2022-06-11 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021356-004 | PED | 2022-06-11 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021356-001 | PED | 2022-06-11 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021356-002 | PED | 2022-06-11 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021356-003 | PED | 2022-06-11 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021356-004 | PED | 2022-06-11 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-001 | NPP | 2021-12-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-001 | PED | 2022-06-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-002 | NPP | 2021-12-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-002 | PED | 2022-06-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-003 | NPP | 2021-12-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-003 | PED | 2022-06-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-004 | NPP | 2021-12-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021356-004 | PED | 2022-06-11 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021356-001 | PED | 2022-06-11 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021356-002 | PED | 2022-06-11 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021356-003 | PED | 2022-06-11 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021356-004 | PED | 2022-06-11 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-001 | NPP | 2021-12-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-001 | PED | 2022-06-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-002 | NPP | 2021-12-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-002 | PED | 2022-06-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-003 | NPP | 2021-12-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-003 | PED | 2022-06-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-004 | NPP | 2021-12-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021356-004 | PED | 2022-06-11 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-001 | NPP | 2021-12-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-001 | PED | 2022-06-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-002 | NPP | 2021-12-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-002 | PED | 2022-06-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-003 | NPP | 2021-12-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-003 | PED | 2022-06-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-004 | NPP | 2021-12-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021356-004 | PED | 2022-06-11 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|---|
| Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | 33fd6418-fbdc-42ca-a50d-ce2a476a5418 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | 021356 NDA021356 61958-0405 61958-0401 61958-0406 61958-0404 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-0754 | Viread | TENOFOVIR DISOPROXIL FUMARATE | A-S Medication Solutions | NDA | Current |
| 50090-0754 | Viread | TENOFOVIR DISOPROXIL FUMARATE | A-S Medication Solutions | NDA | Current |
| 53808-0810 | Viread | tenofovir disoproxil fumarate | State of Florida DOH Central Pharmacy | NDA | Current |
| 61958-0401 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0401 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0401 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0401 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0404 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0404 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0404 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0404 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0405 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0405 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0405 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0405 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0406 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0406 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0406 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 61958-0406 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc. | NDA | Current |
| 69189-0401 | Viread | TENOFOVIR DISOPROXIL FUMARATE | Avera McKennan Hospital | NDA | Current |
| 70518-0546 | Viread | TENOFOVIR DISOPROXIL FUMARATE | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58410 | SUPPL | 2019-04-25 |
| 58393 | SUPPL | 2019-04-24 |
| 56862 | SUPPL | 2018-12-20 |
| 56706 | SUPPL | 2018-12-12 |
| 55069 | SUPPL | 2018-07-31 |
| 55059 | SUPPL | 2018-07-30 |
| 47982 | SUPPL | 2017-04-12 |
| 47913 | SUPPL | 2017-04-10 |
| 27578 | SUPPL | 2016-02-18 |
| 15279 | SUPPL | 2016-02-18 |
| 36744 | SUPPL | 2015-06-04 |
| 27577 | SUPPL | 2015-06-02 |
| 36743 | SUPPL | 2013-10-25 |
| 27576 | SUPPL | 2013-10-25 |
| 15278 | SUPPL | 2013-07-30 |
| 5151 | SUPPL | 2013-07-26 |
| 36742 | SUPPL | 2013-04-09 |
| 27575 | SUPPL | 2013-04-03 |
| 5150 | SUPPL | 2012-08-20 |
| 15277 | SUPPL | 2012-08-17 |
| 5149 | SUPPL | 2012-08-09 |
| 36741 | SUPPL | 2012-08-08 |
| 15275 | SUPPL | 2012-02-01 |
| 27573 | SUPPL | 2012-01-20 |
| 27574 | SUPPL | 2011-11-22 |
| 15276 | SUPPL | 2011-11-22 |
| 5148 | SUPPL | 2011-09-21 |
| 36740 | SUPPL | 2011-09-20 |
| 52368 | SUPPL | 2011-09-06 |
| 52367 | SUPPL | 2011-09-06 |
| 52366 | SUPPL | 2011-09-06 |
| 52365 | SUPPL | 2011-09-06 |
| 52364 | SUPPL | 2011-09-06 |
| 52363 | SUPPL | 2011-09-06 |
| 27572 | SUPPL | 2010-10-19 |
| 15274 | SUPPL | 2010-10-19 |
| 5147 | SUPPL | 2010-10-13 |
| 15273 | SUPPL | 2010-10-12 |
| 27571 | SUPPL | 2010-03-29 |
| 36739 | SUPPL | 2010-03-26 |
| 5146 | SUPPL | 2010-01-25 |
| 15272 | SUPPL | 2009-11-13 |
| 5145 | SUPPL | 2009-11-10 |
| 15271 | SUPPL | 2009-10-14 |
| 36738 | SUPPL | 2008-11-07 |
| 5144 | SUPPL | 2008-11-06 |
| 15270 | SUPPL | 2008-08-29 |
| 5143 | SUPPL | 2008-08-13 |
| 27570 | SUPPL | 2008-05-21 |
| 15269 | SUPPL | 2007-05-29 |
| 5142 | SUPPL | 2007-05-29 |
| 5140 | SUPPL | 2006-03-23 |
| 36736 | SUPPL | 2006-03-10 |
| 36737 | SUPPL | 2005-12-05 |
| 5141 | SUPPL | 2005-12-05 |
| 15268 | SUPPL | 2005-05-17 |
| 5139 | SUPPL | 2005-05-17 |
| 15267 | SUPPL | 2004-07-07 |
| 5138 | SUPPL | 2004-07-06 |
| 15266 | SUPPL | 2003-12-01 |
| 5137 | SUPPL | 2003-11-25 |
| 27569 | SUPPL | 2003-10-16 |
| 15265 | SUPPL | 2003-10-16 |
| 27568 | SUPPL | 2003-08-28 |
| 15264 | SUPPL | 2003-08-28 |
| 15263 | SUPPL | 2002-12-02 |
| 5136 | SUPPL | 2002-12-02 |
| 36735 | ORIG | 2001-10-26 |
| 21613 | ORIG | 2001-10-26 |
| 5135 | ORIG | 2001-10-26 |
| 63282 | SUPPL | 1900-01-01 |
| 63281 | SUPPL | 1900-01-01 |
| 63280 | SUPPL | 1900-01-01 |
| 52374 | ORIG | 1900-01-01 |
| 52373 | ORIG | 1900-01-01 |
| 52372 | ORIG | 1900-01-01 |
| 52371 | ORIG | 1900-01-01 |
| 52370 | ORIG | 1900-01-01 |
| 52369 | ORIG | 1900-01-01 |
| 51678 | ORIG | 1900-01-01 |
| 51677 | ORIG | 1900-01-01 |
| 51676 | ORIG | 1900-01-01 |