Application 091179
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
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 |
|---|---|---|---|---|---|---|---|
| A091179-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | |
| A091179-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | |
| A091179-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091179-001 | AB |
| A091179-002 | AB |
| A091179-003 | 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 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-002 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2010-12-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091179-001 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2010-12-13 | 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 | A091179-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091179-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091179-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091179-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091179-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091179-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091179-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091179-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091179-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091179-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091179-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091179-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091179-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091179-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091179-001 | 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 | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | Warnings, Adverse reactions | 091179 ANDA091179 50090-6216 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | 091179 ANDA091179 43063-405 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 075f052e-7f38-7f75-e063-6394a90a512b | 2026-01-01 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7 | 2025-12-26 | Warnings, Adverse reactions | 091179 ANDA091179 51655-085 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 0b5734b8-6a52-44ff-ac29-9a91a4335394 | 2025-12-20 | Warnings, Adverse reactions | 091179 ANDA091179 53746-521 53746-522 53746-745 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | 091179 ANDA091179 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 12400c65-f93b-47a5-8167-1fb14337130b | 2025-01-07 | Warnings, Adverse reactions | 091179 ANDA091179 43063-447 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 05907a49-537f-4bf2-8a5f-5e905f19fece | 2024-10-30 | Warnings, Adverse reactions | 091179 ANDA091179 65162-745 65162-522 65162-521 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-5195 | Promethazine Hydrochloride | Promethazine Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10135-495 | Promethazine Hydrochloride | promethazine hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-495 | Promethazine Hydrochloride | promethazine hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-495 | Promethazine Hydrochloride | promethazine hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-495 | Promethazine Hydrochloride | promethazine hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-495 | Promethazine Hydrochloride | promethazine hydrochloride | Marlex Pharmaceuticals Inc | ANDA | Current |
| 12634-418 | Promethazine Hydrochloride | Promethazine Hydrochloride | Apotheca, Inc | ANDA | Current |
| 42254-045 | Promethazine Hydrochloride | Promethazine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 42708-119 | Promethazine Hydrochloride | Promethazine Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-119 | Promethazine Hydrochloride | Promethazine Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-119 | Promethazine Hydrochloride | Promethazine Hydrochloride | QPharma Inc | ANDA | Current |
| 43063-405 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-405 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-405 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-405 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-447 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-447 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-447 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-447 | Promethazine Hydrochloride | Promethazine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3588 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3588 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-6216 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-085 | Promethazine hydrochloride | Promethazine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53217-275 | Promethazine Hydrochloride | Promethazine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53746-521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-522 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 53746-745 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 60760-830 | Promethazine Hydrochloride | Promethazine Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-008 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE tablet | Direct Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIERCT RX | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIERCT RX | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIERCT RX | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-047 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-228 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-228 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-228 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-949 | Promethazine Hydrochloride | Promethazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-6875 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6875 | Promethazine Hydrochloride | Promethazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64205-521 | Promethazine Hydrochloride | Promethazine Hydrochloride | ReadyMeds | ANDA | Current |
| 64205-745 | Promethazine Hydrochloride | Promethazine Hydrochloride | ReadyMeds | ANDA | Current |
| 65162-521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
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| 65162-521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-521 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-522 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-522 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-522 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-522 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
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| 65162-745 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-745 | Promethazine Hydrochloride | Promethazine Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
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| 67296-1120 | Promethazine Hydrochloride | Promethazine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
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| 70518-0141 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0141 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0141 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0165 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |