Application 218406
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 12.5MG;40MG | No | No |
| 002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 12.5MG;80MG | No | No |
| 003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 25MG;80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | ||
| A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | ||
| A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET / ORAL | 2025-03-03 |
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 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2025-03-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2025-03-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2025-03-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2025-03-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218406-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2025-03-03 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218406-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2025-03-03 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218406-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2025-03-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A218406-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218406-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218406-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218406-003 | AB | 1 | fd3edfee7708… |
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 and hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Lifestar Pharma LLC | 0c1bd0f4-034e-486c-ae46-2855c8c9ebda | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | 218406 ANDA218406 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.