Application 040863
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040863-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | ||
| A040863-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | ||
| A040863-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 |
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 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040863-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2008-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040863-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2008-12-30 | 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 | A040863-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A040863-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040863-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040863-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040863-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040863-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040863-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040863-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040863-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040863-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040863-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040863-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040863-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040863-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040863-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A040863-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A040863-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040863-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A040863-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A040863-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040863-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040863-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040863-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040863-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A040863-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A040863-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040863-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A040863-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A040863-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040863-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040863-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040863-003 | 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 |
|---|---|---|---|---|---|
| 0615-7668 | promethazine hydrochloride | promethazine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-941 | promethazine hydrochloride | promethazine hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 57664-107 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-108 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-109 | promethazine hydrochloride | promethazine hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 61919-396 | PHENERGAN | PROMWTHAZINE | DIRECT RX | ANDA | Current |
| 61919-396 | PHENERGAN | PROMWTHAZINE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-630 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-038 | promethazine hydrochloride | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-038 | promethazine hydrochloride | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 66267-177 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-177 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-813 | promethazine hydrochloride | promethazine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-0109 | promethazine hydrochloride | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0109 | promethazine hydrochloride | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |