Application 091612
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | No | No |
| 002 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 150MG | No | No |
| 003 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG | No | No |
| 004 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | |
| A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | |
| A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | |
| A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091612-001 | AB |
| A091612-002 | AB |
| A091612-003 | AB |
| A091612-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-001 | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET / ORAL | AB | 2015-03-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-002 | TENOFOVIR DISOPROXIL FUMARATE | 150MG | TABLET / ORAL | AB | 2018-01-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-003 | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET / ORAL | AB | 2018-01-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-004 | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET / ORAL | AB | 2018-01-26 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091612-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091612-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091612-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091612-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091612-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091612-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091612-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091612-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091612-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091612-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091612-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091612-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091612-004 | AB | 1 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7104 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 70518-0918 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0918 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9347 | ORIG | 2015-03-20 |