Application 203986
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 20MG | No | No |
| 002 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 40MG | No | No |
| 003 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203986-001 | TELMISARTAN | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | |
| A203986-002 | TELMISARTAN | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | |
| A203986-003 | TELMISARTAN | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203986-001 | AB |
| A203986-002 | AB |
| A203986-003 | 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 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2025-01-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2025-01-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2025-01-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203986-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203986-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203986-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203986-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203986-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203986-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203986-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203986-003 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203986-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Telmisartan | TELMISARTAN | Redpharm Drug | 5743c58e-deab-ac93-e063-6294a90ac1eb | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 203986 ANDA203986 |
| Telmisartan | TELMISARTAN | Macleods Pharmaceuticals Limited | 671d5a85-4146-43b4-9d7d-ca53268eb2a6 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 203986 ANDA203986 |
| Telmisartan | TELMISARTAN | NorthStar RxLLC | 9c22a318-d1f2-4788-9331-66fed71ebf38 | 2025-12-06 | Boxed warning, Warnings, Adverse reactions | 203986 ANDA203986 |