Application 040596
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
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 |
|---|---|---|---|---|---|---|---|
| A040596-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | |
| A040596-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | |
| A040596-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040596-001 | AB |
| A040596-002 | AB |
| A040596-003 | AB |
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 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2005-11-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040596-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2005-11-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040596-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040596-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040596-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040596-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040596-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040596-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040596-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040596-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040596-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040596-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040596-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040596-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040596-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040596-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040596-001 | AB | 1 | 8072bd15b7f6… |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 0615-8154 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ea490539-007b-47b1-bef9-22de02ae7c64 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8749824b-6d66-430d-e053-2995a90a2db8 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 68071-4865 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | da246971-20b8-b46e-8366-9700d3604cf1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 63629-1591 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | b4985d9d-1aa0-4b36-bc98-6a5410ad9bad | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | c0c0d4f0-8396-485b-a585-71df01491f6f | 2023-11-07 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 68382-040 68382-042 68382-041 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Proficient Rx LP | dcb1694a-8451-403c-b848-edb89ba17020 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 87429921-00d2-42c7-9e99-600e8075b8ce | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 50090-4812 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Proficient Rx LP | 59b906c6-2ccc-416e-b3ee-db09bf553146 | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | 040596 ANDA040596 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-1539 | Promethazine | Promethazine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8154 | Promethazine Hydrochloride | Promethazine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-512 | Promethazine Hydrochloride | Promethazine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-589 | Promethazine Hydrochloride | Promethazine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-885 | Promethazine Hydrochloride | Promethazine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 50090-4811 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4811 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4812 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4812 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4813 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4813 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4875 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4875 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51655-112 | Promethazine Hydrochloride | Promethazine Hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-114 | Promethazine hydrochloride | Promethazine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-588 | Promethazine hydrochloride | Promethazine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 52959-534 | Promethazine Hydrochloride | Promethazine Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-4021 | Promethazine Hydrochloride | Promethazine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0545 | Promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4775 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health | ANDA | Current |
| 60687-660 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 60760-456 | Promethazine Hydrochloride | Promethazine Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-456 | Promethazine Hydrochloride | Promethazine Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-1591 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1591 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1591 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8187 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64725-0041 | Promethazine Hydrochloride | Promethazine Hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 65841-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 67296-0198 | Promethazine Hydrochloride | Promethazine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0198 | Promethazine Hydrochloride | Promethazine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68001-161 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-161 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-162 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-162 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-163 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-163 | Promethazine Hydrochloride | Promethazine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68071-4809 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4809 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4809 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4865 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4865 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4865 | Promethazine Hydrochloride | Promethazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-154 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-154 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-154 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-155 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-155 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-155 | Promethazine Hydrochloride | Promethazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68382-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-040 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-041 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-042 | Promethazine Hydrochloride | Promethazine Hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-7886 | Promethazine Hydrochloride | Promethazine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7886 | Promethazine Hydrochloride | Promethazine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1306 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2488 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2488 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2488 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |