Application 040712
- Type
- ANDA
- Sponsor
- KVK TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | 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 |
|---|---|---|---|---|---|---|---|
| A040712-001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | |
| A040712-002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | |
| A040712-003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040712-001 | AB |
| A040712-002 | AB |
| A040712-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-002 | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AB | 2007-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-003 | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2006-07-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040712-001 | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2006-07-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040712-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040712-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040712-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040712-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040712-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040712-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040712-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040712-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040712-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040712-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040712-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040712-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040712-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040712-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040712-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040712-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040712-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040712-001 | AB | 1 | 301d65b070ca… |
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. | 6bcaa89f-5f14-dc45-e053-2a91aa0aac54 | 2026-07-30 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 804e2525-d61f-7bed-e053-2991aa0a5daa | 2026-06-30 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488 | 2026-06-05 | Warnings, Adverse reactions | 040712 ANDA040712 71335-1359 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47 | 2026-06-04 | Warnings, Adverse reactions | 040712 ANDA040712 71335-0989 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8 | 2026-05-22 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f93ca67d-362a-473f-8296-2952da77c074 | 2026-05-22 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d | 2026-05-22 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | KVK-Tech, Inc. | 7a137adf-39b7-4b14-80da-c3cac9ad562a | 2026-03-13 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | d9cb1a44-d646-d9e9-e053-2995a90a24ff | 2026-01-01 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7e5715cf-056f-4095-e053-2991aa0ad3e5 | 2024-06-12 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9 | 2023-12-15 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b54439a3-1d01-4c5f-8508-731790ae215b | 2023-12-15 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b96904e7-cc67-4abc-b946-8423f3f897ff | 2023-10-24 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 2c9a4767-23c4-4a1c-bb4c-2bad1351c270 | 2023-05-08 | Warnings, Adverse reactions | 040712 ANDA040712 |
| Promethazine | PROMETHAZINE | PharmPak, Inc. | 4f681538-7ac4-484c-9e6d-b571d73b9e0b | 2022-10-08 | Warnings, Adverse reactions | 040712 ANDA040712 |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Proficient Rx LP | 29a8b172-1bad-40db-8d73-1fe7fb309cff | 2022-04-01 | Warnings, Adverse reactions | 040712 ANDA040712 71205-126 |
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 |
|---|---|---|---|---|---|
| 70518-0519 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0519 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0519 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0519 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0519 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0778 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0778 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0778 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-243 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-243 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-243 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-449 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-449 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-126 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-126 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-126 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-126 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0989 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0989 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0989 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1359 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1359 | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29963 | ORIG | 2006-08-11 |