Application 020942
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERSED | MIDAZOLAM HYDROCHLORIDE | SYRUP;ORAL | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020942-001 | VERSED | MIDAZOLAM HYDROCHLORIDE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 |
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| 2026-08 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020942-001 | VERSED | EQ 2MG BASE/ML | SYRUP / ORAL | RLD | 1998-10-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020942-001 | VERSED | EQ 2MG BASE/ML | SYRUP / ORAL | RLD | 1998-10-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 1998-10-15 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020942-001 | VERSED | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 1998-10-15 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Steriscience Specialties Private Limited | 473fba4b-8754-4b1d-bba9-d9c8f6d818e0 | 2023-12-13 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | SOMERSET THERAPEUTICS, LLC | 74666098-1ca8-4c06-8fc4-5de870b1b514 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | SOMERSET THERAPEUTICS, LLC | 06e4f754-72df-4eb4-aaed-b538524f5277 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| midazolam | MIDAZOLAM HYDROCHLORIDE | Sagent Pharmaceuticals | 880cac48-5c0f-49a9-8aef-3c9770bf5d84 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| midazolam | MIDAZOLAM HYDROCHLORIDE | Sagent Pharmaceuticals | e22611dd-1830-40af-9139-7cdb07f5a426 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Bryant Ranch Prepack | 1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc | 2023-10-25 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Gland Pharma Limited | 81b2f48d-a05c-4301-8fee-761af220d44f | 2023-10-16 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam hydrochloride | MIDAZOLAM HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 843cc25e-45ea-4372-ae34-843f805fa869 | 2023-03-20 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Padagis US LLC | 0be63f63-6a93-4782-8f9c-d13ca5ae44bd | 2022-12-06 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam hydrochloride | MIDAZOLAM HYDROCHLORIDE | Gland Pharma Limited | 23f4df96-1151-4815-8f01-4d79e5aa2145 | 2022-11-11 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.