Application 040504
- Type
- ANDA
- Sponsor
- ABLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 12.5MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | SUPPOSITORY;RECTAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040504-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | ||
| A040504-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 |
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 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040504-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY / RECTAL | 2003-04-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040504-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY / RECTAL | 2003-04-11 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 84899861-8fed-536d-e053-2991aa0a42b2 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 07914b6e-c40f-44be-a1db-8724c70f99b6 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ea490539-007b-47b1-bef9-22de02ae7c64 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | a4b3da5b-1129-43c2-bf22-3a29c3fae116 | 2024-07-30 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8749824b-6d66-430d-e053-2995a90a2db8 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7e5715cf-056f-4095-e053-2991aa0ad3e5 | 2024-06-12 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 4bf3912c-8339-401e-9711-dad6acf15f11 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 481866da-a712-48a5-853f-8e84aacaab6d | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 365138a6-28d8-4881-a3e9-02c80aaf83e8 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | da246971-20b8-b46e-8366-9700d3604cf1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | b4985d9d-1aa0-4b36-bc98-6a5410ad9bad | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | b6f6698f-f23c-452a-9b38-bbb96ab88ae4 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | XGen Pharmaceuticals DJB, Inc. | 1d02d52b-84bb-4e81-b352-125029eb39f6 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9 | 2023-12-15 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b54439a3-1d01-4c5f-8508-731790ae215b | 2023-12-15 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | Cosette Pharmaceuticals, Inc. | 5f079815-f48b-8b21-2130-7f791d967c9a | 2023-11-30 | Boxed warning, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | Cosette Pharmaceuticals, Inc. | 636bb9bc-0cc5-4d6a-85be-6471acf01ffc | 2023-11-30 | Boxed warning, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | c0c0d4f0-8396-485b-a585-71df01491f6f | 2023-11-07 | Boxed warning, Warnings, Adverse reactions | Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.