Application 075558
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VECURONIUM BROMIDE | VECURONIUM BROMIDE | INJECTABLE;INJECTION | 4MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075558-001 | VECURONIUM BROMIDE | VECURONIUM BROMIDE | 4MG/VIAL | INJECTABLE / INJECTION | 2001-09-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A075558-001 | VECURONIUM BROMIDE | 4MG/VIAL | INJECTABLE / INJECTION | 2001-09-11 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075558-001 | VECURONIUM BROMIDE | 4MG/VIAL | INJECTABLE / INJECTION | 2001-09-11 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075558-001 | VECURONIUM BROMIDE | 4MG/VIAL | INJECTABLE / INJECTION | 2001-09-11 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075558-001 | VECURONIUM BROMIDE | 4MG/VIAL | INJECTABLE / INJECTION | 2001-09-11 | 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 |
|---|---|---|---|---|---|---|
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | HF Acquisition Co LLC, DBA HealthFirst | 582c7f44-b614-18df-e063-6294a90a74b6 | 2026-08-03 | Warnings, Adverse reactions | VECURONIUM BROMIDE VECURONIUM BROMIDE |
| vecuronium bromide | VECURONIUM BROMIDE | Sun Pharmaceutical Industries, Inc. | a14da3ee-a731-4282-be9d-407473517470 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | vecuronium bromide VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Phlow Corp. | b012b1b1-9e59-4525-8f4d-dae98344d15f | 2026-03-19 | Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Hikma Pharmaceuticals USA Inc. | dceeec01-2910-4489-8d70-9c0c711d17ab | 2026-01-29 | Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Mullan Pharmaceutical Inc. | aa35d139-25c8-4802-b165-0db7d1c08913 | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Meitheal Pharmaceuticals Inc. | 53653418-0464-4cd2-a987-3d31be36098f | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Eugia US LLC | 387b57ce-e50e-4e03-86d9-12638242bd36 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Sagent Pharmaceuticals | dff452e8-71e7-437e-bed0-3e1bd9441bc6 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | HF Acquisition Co LLC, DBA HealthFirst | e51c763e-2819-341f-e053-2995a90a0565 | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Eugia US LLC | 86d81719-534c-4e50-ae39-d8b20e50dfad | 2023-12-06 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Mylan Institutional LLC | 96e69586-e9af-4b07-990f-12d93faa7edd | 2022-10-31 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Gland Pharma Limited | 5ae91612-4f65-4e52-8901-c37010612eaf | 2018-07-16 | Boxed warning, Warnings, Adverse reactions | Vecuronium Bromide VECURONIUM BROMIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8715 | ORIG | 2003-04-14 |