Application 071980
- Type
- ANDA
- Sponsor
- QUANTUM PHARMICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | TABLET;ORAL | 50MG;75MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET / ORAL | 1988-04-17 |
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 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A071980-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 50MG;75MG | TABLET / ORAL | 1988-04-17 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Sandoz Inc | f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | f083c321-3170-4982-b5cd-d3fdff754857 | 2026-07-08 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 0de72197-607f-ef0a-e063-6394a90a8949 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 03b11335-2e88-2f7b-e063-6394a90afe2a | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 43425ec7-a2c0-41d8-b759-b7b5918949ce | 2026-06-01 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | St. Mary's Medical Park Pharmacy | de5e7c85-5bf5-5b5f-e053-2995a90a1fba | 2026-06-01 | Boxed warning, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f3bc491a-961d-4a38-8a55-c4a03be05b74 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | e7c34985-a8be-45d3-9273-2b13e2f6b7b2 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | bdd4348d-928d-ef0b-e053-2a95a90aadb4 | 2026-02-20 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Apotex Corp. | bd6c3495-ec70-908b-482a-a979506659e9 | 2026-02-17 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Golden State Medical Supply, Inc. | 9fe534cd-cf5f-64b4-e053-2995a90a926e | 2026-02-12 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals, Inc. | 6c4cd90b-44c0-4da5-8f26-f0fa465acce4 | 2026-01-13 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Advagen Pharma Ltd | a5525a2a-d2c7-411b-9ffc-0cc4fe77f7c7 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f32b8809-80e9-18f2-e053-2995a90a5428 | 2026-01-01 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 9ec3d35f-b25d-48f4-926f-f093e402ccde | 2026-01-01 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | db895e64-3f97-9201-e053-2a95a90ac7ef | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 08f3885e-dfde-79e4-e063-6394a90a4c09 | 2025-12-26 | Boxed warning, Adverse reactions | Triamterene and Hydrochlorothiazide |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Chartwell RX, LLC | 261dd83f-8048-488f-8b71-c4abd9692720 | 2025-12-10 | Adverse reactions | TRIAMTERENE AND HYDROCHLOROTHIAZIDE |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | e505484d-b600-4d13-a4b9-278dc4a2e73a | 2025-10-20 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | 860bed38-26f2-49bb-9dba-8928cec3c42c | 2025-10-20 | Warnings, Adverse reactions | Triamterene and Hydrochlorothiazide |