Application 083176
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REMSED | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | REMSED | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083176-001 | REMSED | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | ||
| A083176-002 | REMSED | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A083176-001 | REMSED | 50MG | TABLET / ORAL | Approved before 1982 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A083176-002 | REMSED | 25MG | TABLET / ORAL | Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 55f618d1-4466-3200-e063-6394a90a89a8 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Sportpharm LLC | 4156e780-7ecf-bcae-e063-6394a90a2ae2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ASCLEMED USA INC. | 4d30e587-6d59-4cf5-ab45-c7639f759df9 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5590f356-0904-58f6-e063-6294a90a6ad5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 804e2525-d61f-7bed-e053-2991aa0a5daa | 2026-06-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488 | 2026-06-05 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47 | 2026-06-04 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8 | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f93ca67d-362a-473f-8296-2952da77c074 | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d | 2026-05-22 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 4f99bbd5-02f7-2fed-e063-6394a90a6355 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | KVK-Tech, Inc. | 7a137adf-39b7-4b14-80da-c3cac9ad562a | 2026-03-13 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | bae9c9c1-107f-0fcb-e053-2a95a90a75b2 | 2026-03-05 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | 7fa840ad-10e7-4faf-9325-451648604161 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | adb04635-584f-4fef-98ca-2574be312a73 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell RX, LLC | 2ca17cd4-460e-4d54-8c53-a58a2b80e5cb | 2026-01-30 | Warnings, Adverse reactions | PROMETHAZINE HYDROCHLORIDE |