Application 209721
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 100MG;150MG | No | No |
| 002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 133MG;200MG | No | No |
| 003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 167MG;250MG | No | No |
| 004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG;300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | |
| A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | |
| A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | |
| A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209721-001 | AB |
| A209721-002 | AB |
| A209721-003 | AB |
| A209721-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-001 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | 2018-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-002 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | 2018-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-003 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | 2018-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-004 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | 2018-08-22 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209721-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209721-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209721-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209721-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209721-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209721-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209721-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209721-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209721-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209721-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209721-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209721-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209721-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209721-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209721-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209721-004 | AB | 1 | 5bbf6a4d5a75… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A209721-001 | PC | 2021-03-09 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209721-002 | PC | 2021-03-09 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209721-003 | PC | 2021-03-09 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209721-001 | PC | 2021-03-09 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209721-002 | PC | 2021-03-09 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209721-003 | PC | 2021-03-09 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209721-001 | PC | 2021-03-09 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A209721-002 | PC | 2021-03-09 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A209721-003 | PC | 2021-03-09 | 5aa47cf7b7d7… |
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 |
|---|---|---|---|---|---|---|
| Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Amneal Pharmaceuticals NY LLC | 94d78028-4ba5-4a5d-bd6f-5eca2a1b4b9d | 2021-08-28 | Boxed warning, Warnings, Adverse reactions | 209721 ANDA209721 60219-2095 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Amneal Pharmaceuticals NY LLC | b0459301-2bff-4336-9172-b90c7a582433 | 2020-11-29 | Boxed warning, Warnings, Adverse reactions | 209721 ANDA209721 69238-2092 69238-2095 69238-2093 69238-2094 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-439 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | AvKARE | ANDA | Current |
| 42291-439 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | AvKARE | ANDA | Current |
| 60219-2092 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2093 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2094 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1527 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1527 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1527 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1547 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1547 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1547 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1548 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1548 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1548 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1549 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1549 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1549 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2092 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2092 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2092 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2093 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2093 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2093 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2094 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2094 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2094 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-2095 | Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | Amneal Pharmaceuticals NY LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55405 | ORIG | 2018-09-07 |