Application 218454
- Type
- ANDA
- Sponsor
- B BRAUN MEDICAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | Yes |
| 002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | |
| A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218454-001 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218454-002 | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RS | 2025-05-01 | a50c72e98297… |
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 IN 0.8% SODIUM CHLORIDE | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | B. Braun Medical Inc. | adfe8ece-496d-4118-9990-a1d44d0ac7d9 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 218454 ANDA218454 |