Application 083312
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | No | Yes |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083312-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| A083312-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A083312-001 | AP |
| A083312-002 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083312-001 | PROMETHAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083312-002 | PROMETHAZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A083312-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A083312-002 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A083312-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A083312-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A083312-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A083312-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A083312-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A083312-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083312-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083312-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A083312-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A083312-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083312-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083312-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083312-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083312-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083312-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083312-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083312-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083312-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083312-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083312-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083312-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083312-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A083312-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A083312-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083312-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083312-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083312-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083312-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083312-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083312-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A083312-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A083312-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083312-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083312-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A083312-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A083312-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A083312-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A083312-002 | AP | 1 | 4b0b4de00fa7… |
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 | Henry Schein, Inc. | 7fa840ad-10e7-4faf-9325-451648604161 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0404-9940 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7ce351d8-47be-4937-aad2-153208c93b53 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 55154-2861 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 38673af1-112e-9ddd-e063-6294a90af465 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0404-9941 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0404-9942 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 13d9e59d-eadb-41d5-9f47-9c11a6efb31c | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-1495 0641-1496 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d545105f-27dc-4820-b0b1-fcf17e0be0f0 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-0948 0641-0949 |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 6f7e47cc-f823-4336-8107-f980e3049617 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-6082 0641-6083 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 4bf3912c-8339-401e-9711-dad6acf15f11 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-0928 0641-0929 |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 481866da-a712-48a5-853f-8e84aacaab6d | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-6085 0641-6084 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-6208 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 365138a6-28d8-4881-a3e9-02c80aaf83e8 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 0641-0955 0641-0956 |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 51662-1248 |
| PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 51662-1247 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 677b5fc5-94be-638b-e053-2991aa0a7f97 | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 71872-7077 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | dc8b50de-e4f6-607f-e053-2995a90a2902 | 2023-05-02 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 71872-7285 |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | c930985b-bba3-4f3a-a1ae-1d808670efde | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | 083312 ANDA083312 50090-0879 |
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 |
|---|---|---|---|---|---|
| 0404-9940 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | ANDA | Current |
| 0404-9940 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | ANDA | Current |
| 0404-9941 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9941 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9941 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9942 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9942 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9942 | Promethazine Hydrochloride | Promethazine Hydrochloride | Henry Schein, Inc. | ANDA | Current |
| 0641-0928 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0928 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0929 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0929 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0948 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0948 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0949 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0949 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0955 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0955 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-0956 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-0956 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-1495 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-1495 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-1496 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-1496 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6082 | PHENERGAN | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6082 | PHENERGAN | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6083 | PHENERGAN | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6083 | PHENERGAN | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6084 | PHENERGAN | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6084 | PHENERGAN | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6085 | PHENERGAN | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6085 | PHENERGAN | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6099 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-ward Pharmaceutical Corp. | ANDA | Current |
| 0641-6208 | Promethazine Hydrochloride | Promethazine Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6208 | Promethazine Hydrochloride | Promethazine Hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 50090-0879 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0879 | Promethazine Hydrochloride | Promethazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51662-1247 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1247 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1247 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1247 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1247 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1248 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1248 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1248 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1248 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 51662-1248 | PROMETHAZINE HCI | PROMETHAZINE HCI | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | Current |
| 52584-078 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-078 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-078 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-495 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-495 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-495 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-495 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-496 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-496 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-496 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-496 | Promethazine Hydrochloride | Promethazine Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 55154-2860 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2860 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2861 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2861 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2861 | Promethazine Hydrochloride | Promethazine Hydrochloride | Cardinal Health | ANDA | Current |
| 68258-3028 | Promethazine Hydrochloride | Promethazine Hydrochloride | Dispensing Solutions Inc. | ANDA | Current |
| 70518-2656 | PHENERGAN | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2656 | PHENERGAN | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2896 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2896 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3340 | Promethazine Hydrochloride | Promethazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71872-7077 | Promethazine Hydrochloride | Promethazine Hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7077 | Promethazine Hydrochloride | Promethazine Hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7285 | Promethazine Hydrochloride | Promethazine Hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |