Application 083040
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083040-001 | SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 |
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 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A083040-001 | SONAZINE | 10MG/5ML | SYRUP / ORAL | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 41b86f9d-d7e2-4296-8d88-e8257c7cbed2 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | American Health Packaging | 85ab0b93-c716-4889-87db-9e76e75df7c7 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Aurobindo Pharma Limited | c2a8b8a3-187f-4000-bde3-b40bb0e5600f | 2026-05-25 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | aa086a21-de85-4b03-af58-49b70acf8cf0 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | REMEDYREPACK INC. | d3b09b67-e8da-450d-8a52-b3c40605de26 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | REMEDYREPACK INC. | b8137906-946c-455d-87c0-0e130cd9266f | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 2122d619-3f5b-48f6-8f0b-7693199abbdb | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Saptalis Pharmaceuticals, LLC. | cd8f9e23-d08a-4d96-8fe9-35ab2bc861c8 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 5ae79c1e-f523-4358-9f8b-7382a03d59bc | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | REMEDYREPACK INC. | c2a38be8-43e6-4a56-9556-fe3dad412b82 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | c0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | AvPAK | 9e8cebc0-7fcf-dca8-e053-2a95a90a3369 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Coupler LLC | 472e9a45-4060-3b2a-e063-6294a90a716a | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | c212a2a1-323a-8b61-e053-2995a90a5b04 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| chlorpromazine hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Chartwell RX, LLC | e9d6a9e9-ba25-4c25-9b03-25897a3ac5f3 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | Eugia US LLC | 07e6144a-b460-4887-b8e2-dd371c14a55c | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | American Health Packaging | d43718e5-66d7-44f9-9fc8-80d38d3e41ce | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| Chlorpromazine Hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | d37a4c21-b503-4791-a4d0-2ccc8891d88e | 2025-11-04 | CHLORPROMAZINE HYDROCHLORIDE | |
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | Henry Schein, Inc. | 310d161e-c4db-49e8-8665-d1a6d4e11320 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |
| chlorpromazine hydrochloride | CHLORPROMAZINE HYDROCHLORIDE | Advagen Pharma Ltd | 02c56c39-99bd-44a4-8d9d-9d867c323968 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | CHLORPROMAZINE HYDROCHLORIDE |