Application 090529
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090529-001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | ||
| A090529-002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | ||
| A090529-003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 |
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 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090529-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090529-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090529-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2011-12-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A090529-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090529-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090529-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090529-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090529-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090529-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090529-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090529-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090529-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090529-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090529-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090529-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090529-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090529-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090529-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A090529-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A090529-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090529-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A090529-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A090529-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090529-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090529-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090529-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090529-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A090529-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A090529-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090529-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A090529-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A090529-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090529-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090529-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090529-003 | AB | 1 | 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.
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 |
|---|---|---|---|---|---|
| 43063-561 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-561 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-561 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-562 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-562 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-992 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 53808-1019 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-650 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-650 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57664-116 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-116 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-117 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-117 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-118 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-118 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 68071-4663 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4663 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-0625 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-0928 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0928 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |