Application 019129
- Type
- NDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MAXZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | TABLET;ORAL | 50MG;75MG | Yes | Yes |
| 003 | MAXZIDE-25 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | TABLET;ORAL | 25MG;37.5MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019129-001 | MAXZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 |
| N019129-003 | MAXZIDE-25 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019129-001 | AB |
| N019129-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019129-001 | MAXZIDE | 50MG;75MG | TABLET / ORAL | AB | RLD, RS | 1984-10-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019129-003 | MAXZIDE-25 | 25MG;37.5MG | TABLET / ORAL | AB | RLD | 1988-05-13 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019129-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N019129-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N019129-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019129-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019129-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019129-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019129-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019129-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019129-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019129-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019129-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019129-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019129-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019129-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019129-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019129-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019129-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019129-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019129-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019129-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019129-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019129-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019129-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019129-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019129-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019129-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019129-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019129-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019129-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019129-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N019129-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N019129-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019129-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019129-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N019129-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N019129-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N019129-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N019129-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N019129-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019129-003 | AB | 1 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|
| 0378-0460 | MAXZIDE | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0460 | MAXZIDE | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0460 | MAXZIDE | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0464 | MAXZIDE-25 | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0464 | MAXZIDE-25 | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-0464 | MAXZIDE-25 | maxzide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1352 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1352 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1352 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1352 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1355 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1355 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1355 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-1355 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Pharmaceuticals Inc. | NDA | Current |
| 10544-076 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Blenheim Pharmacal, Inc. | NDA | Current |
| 43063-424 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-424 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-424 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-424 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 43063-424 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 51079-433 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Institutional Inc. | NDA | Current |
| 51079-433 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Institutional Inc. | NDA | Current |
| 51079-433 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Mylan Institutional Inc. | NDA | Current |
| 55700-191 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 63629-6404 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Bryant Ranch Prepack | NDA | Current |
| 63629-6404 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Bryant Ranch Prepack | NDA | Current |
| 63629-6712 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Bryant Ranch Prepack | NDA | Current |
| 63629-6712 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Bryant Ranch Prepack | NDA | Current |
| 63629-6712 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Bryant Ranch Prepack | NDA | Current |
| 67544-102 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-102 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-408 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 67544-408 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 68788-9793 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Preferred Pharmaceuticals | NDA | Current |