Application 075401
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | No | No |
| 004 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 005 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 360MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075401-001 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | ||
| A075401-002 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | ||
| A075401-003 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | ||
| A075401-004 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | ||
| A075401-005 | TAZTIA XT | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 |
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 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075401-001 | TAZTIA XT | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075401-002 | TAZTIA XT | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075401-003 | TAZTIA XT | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075401-004 | TAZTIA XT | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075401-005 | TAZTIA XT | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | 2003-04-10 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075401-001 | AB4 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075401-002 | AB4 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075401-003 | AB4 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075401-004 | AB4 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075401-005 | AB4 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075401-001 | AB4 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075401-002 | AB4 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075401-003 | AB4 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075401-004 | AB4 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075401-005 | AB4 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075401-001 | AB4 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075401-002 | AB4 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075401-003 | AB4 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075401-004 | AB4 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075401-005 | AB4 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075401-001 | AB4 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075401-002 | AB4 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075401-003 | AB4 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075401-004 | AB4 | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075401-005 | AB4 | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075401-001 | AB4 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075401-002 | AB4 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075401-003 | AB4 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075401-004 | AB4 | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075401-005 | AB4 | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075401-001 | AB4 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075401-002 | AB4 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075401-003 | AB4 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075401-004 | AB4 | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075401-005 | AB4 | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075401-001 | AB4 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075401-002 | AB4 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075401-003 | AB4 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075401-004 | AB4 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075401-005 | AB4 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075401-001 | AB4 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075401-002 | AB4 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075401-003 | AB4 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075401-004 | AB4 | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075401-005 | AB4 | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 762c3007-b22f-4d35-87b4-191fec8b3a9a | 2023-11-20 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 2023-11-20 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | eebf29fe-ce22-4482-b850-5854550bf2c4 | 2023-08-04 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 225a87fb-d353-4ee7-bd08-14d631ff6b16 | 2023-06-07 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9f69371d-3ede-285d-e053-2a95a90a6e42 | 2023-05-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Proficient Rx LP | a24255a3-88b1-47ef-90fc-51619a1c5a63 | 2023-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 5460158f-7782-45f4-89b1-f84e6ba178d8 | 2023-01-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 6f71ba5e-7bd6-409a-80c6-2f22d975aefc | 2023-01-09 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Oceanside Pharmaceuticals | f6a24de7-8ffe-48af-873f-10fdcd5551d1 | 2020-06-02 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 609e97e5-ebc7-4268-84ea-f279284c89e2 | 2020-01-19 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 24658-341 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-342 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-343 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-344 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 24658-345 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-696 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-697 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-698 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-699 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-700 | TAZTIA | Diltiazem Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |